MILK OF MAGNESIA CHERRY- magnesium hydroxide liquid

MILK OF MAGNESIA CHERRY by

Drug Labeling and Warnings

MILK OF MAGNESIA CHERRY by is a Otc medication manufactured, distributed, or labeled by FREDS, INC, GCP Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 15 mL tablespoonful)

Magnesium hydroxide 1200 mg

Purpose

Saline laxative

Uses

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

Warnings

Ask a doctor before use if you have

• a magnesium-restricted diet
• kidney disease
• 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 failure to have a 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.

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 use if under restricted sugar diet
• 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 of (8oz) of liquid with each dose

• age: dose
• adults and children 12 years and over: 2 to 4 tablespoonfuls
• children 6 years to 11 years: 1 to 2 tablespoonfuls
• children under 6 years: ask a doctor

Other information

• each tablespoonful contains: magnesium 500 mg, sodium 6 mg
• do not freeze
• store at room temperature tightly closed

Inactive ingredients

carboxymethylcellulose sodium, citric acid, D&C red no. 28, flavor, glycerin,
microcrystalline cellulose, purified water, sodium citrate, sodium hypochlorite, sucrose, xanthan gum

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

MILK OF MAGNESIA CHERRY 
magnesium hydroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-648
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	1200 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	pink (opaque light pink)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-648-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2014
2	NDC: 55315-648-26	769 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/01/2014

Labeler - FREDS, INC (005866116)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	pack(55315-648) , manufacture(55315-648)