Milk Of Magnesia Original Liquid
FDA Label NDC 60687-429

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Health Packaging for the product Milk Of Magnesia Original (NDC 60687-429). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each 30 ml cup), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each 30 Ml Cup)

→ Purpose

→ Uses

→ Warnings

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Packaging Information

→ Principal Display Panel – Tray

→ Principal Display Panel – Cup

Active Ingredient (In Each 30 Ml Cup)

Magnesium hydroxide 2400 mg

Purpose

Saline laxative

Uses

relieves occasional constipation (irregularity)
usually produces bowel movement in 1/2 to 6 hours

Warnings

Ask a doctor before use if you have

kidney disease
a magnesium-restricted diet
stomach pain, nausea, or vomiting
a sudden change in bowel habits that lasts over 14 days

Ask a doctor or pharmacist before use if you are
taking a prescription drug.

This product may interact with certain prescription drugs.

Stop use and ask a doctor if

you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
you need to use a laxative for more than 1 week

If pregnant or breast-feeding,
ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

shake well before use
do not exceed the maximum recommended daily dose in a 24 hour period
dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor
drink a full glass (8 oz) of liquid with each dose

adults and children 12 years and older	1 unit dose cup (30 mL) to 2 unit dose cups (60 mL)
children 6 to 11 years	½ unit dose cup (15 mL) to 1 unit dose cup (30 mL)
children under 6 years	ask a doctor

Other Information

each 30 mL cup contains: magnesium 1000 mg
store at room temperature and avoid freezing
DO NOT USE IF SEAL IS BROKEN
This drug product is supplied in 30 ml unit dose cups as:
100 cups (10 x 10) ND 60687-429-76

Inactive Ingredients

purified water, sodium hypochlorite

Packaging Information

American Health Packaging unit dose cups (see Other Information section) contain drug product from Geri-Care Pharmaceuticals as follows:
(2400 mg per 30 mL / 100 UD) NDC 60687-429-76 packaged from NDC 57896-649

Distributed by:
American Health Packaging
Columbus, OH 43217

8442972/0920F