Mineral Oil Oral emulsion

What is this medicine?

MINERAL OIL (MIN-ah-rel OIL) is a laxative. This medicine is used to relieve occasional constipation or stool impaction.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• abdominal pain

• blood in your stool (black or tarry stools) or if you have blood in your vomit

• stomach or intestinal problems

• difficulty swallowing

• bedridden

• an unusual or allergic reaction to mineral oil, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a full glass of water. Follow the directions on the package label. Shake well before use. Do not take with food. Do not take this medicine before bedtime. Take it earlier in the day. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not use for longer than 1 week without advice of your health care professional.

Talk to your pediatrician regarding the use of this medicine in children. While this medicine may be used in children as young as 6 years of age, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• dietary supplements like beta-carotene and vitamins A, D, E, and K

• docusate sodium

• estrogens and estrogen-containing birth control pills

• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your symptoms do not start to get better or get worse. Do not use this medicine for longer than directed by your doctor or health care professional. This medicine can be habit-forming. Long-term use can make your body depend on the laxative for regular bowel movements, damage the bowel, cause malnutrition, and problems with the amounts of water and salts in your body. If your constipation keeps returning, check with your doctor or health care professional.

Drink fluids as directed to prevent dehydration and to assist stool passage.

If you take a vitamin supplement, take the supplement 1 hour before or 4 hours after a dose of mineral oil to limit any interaction.

If stools become loose or you have diarrhea, discontinue use and consult your doctor or health care professional for advice, if necessary.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• diarrhea that is severe

• difficulty breathing or shortness of breath

• unusually weak or tired

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• leakage of oil from rectum or rectal skin irritation

• loose stools

• lower stomach discomfort or cramps

• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Mineral Oil Oral solution

What is this medicine?

MINERAL OIL (MIN-ah-rel OIL) is a laxative. This medicine is used to relieve occasional constipation or stool impaction.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• abdominal pain

• blood in your stool (black or tarry stools) or if you have blood in your vomit

• stomach or intestinal problems

• difficulty swallowing

• bedridden

• an unusual or allergic reaction to mineral oil, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a full glass of water. Follow the directions on the package label. Shake well before use. Do not take with food. Do not take this medicine before bedtime. Take it earlier in the day. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not use for longer than 1 week without advice of your health care professional.

Talk to your pediatrician regarding the use of this medicine in children. While this medicine may be used in children as young as 6 years of age, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• dietary supplements like beta-carotene and vitamins A, D, E, and K

• docusate sodium

• estrogens and estrogen-containing birth control pills

• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your symptoms do not start to get better or get worse. Do not use this medicine for longer than directed by your doctor or health care professional. This medicine can be habit-forming. Long-term use can make your body depend on the laxative for regular bowel movements, damage the bowel, cause malnutrition, and problems with the amounts of water and salts in your body. If your constipation keeps returning, check with your doctor or health care professional.

Drink fluids as directed to prevent dehydration and to assist stool passage.

If you take a vitamin supplement, take the supplement 1 hour before or 4 hours after a dose of mineral oil to limit any interaction.

If stools become loose or you have diarrhea, discontinue use and consult your doctor or health care professional for advice, if necessary.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• diarrhea that is severe

• difficulty breathing or shortness of breath

• unusually weak or tired

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• leakage of oil from rectum or rectal skin irritation

• loose stools

• lower stomach discomfort or cramps

• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Mineral Oil Rectal enema, emulsion

What is this medicine?

MINERAL OIL (MIN-ah-rel OIL) is a laxative. This medicine is used to relieve occasional constipation or stool impaction.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• abdominal pain

• blood in your stool (black or tarry stools) or if you have blood in your vomit

• stomach or intestinal problems

• an unusual or allergic reaction to mineral oil, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for rectal use only. Do not take by mouth. Follow the directions on the label. Wash your hands before and after use. Remove tip from enema. Gently insert enema tip into the rectum as directed. Squeeze the enema until the prescribed dose has been given. Gently remove enema tip from the rectum. Throw away any leftover medicine in the enema; do not reuse. Do not use more often than directed. Do not use for longer than 1 week without advice of your health care professional.

Talk to your pediatrician regarding the use of this medicine in children. While this medicine may be used in young children, they do not receive the full enema dose and precautions do apply. Use only if advised by your pediatrician.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

• docusate

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your symptoms do not start to get better or get worse. Do not use this medicine for longer than directed by your doctor or health care professional. This medicine can be habit-forming. Long-term use can make your body depend on the laxative for regular bowel movements, damage the bowel, cause malnutrition, and problems with the amounts of water and salts in your body. If your constipation keeps returning, check with your doctor or health care professional.

Drink fluids as directed to prevent dehydration and to assist stool passage.

If stools become loose or you have diarrhea, discontinue use and consult your doctor or health care professional for advice, if necessary.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• diarrhea that is severe

• difficulty breathing or shortness of breath

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• leakage of oil from rectum or rectal skin irritation

• loose stools

• lower stomach discomfort or cramps

• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.