Drug Facts

Active Ingredient

Magnesium Carbonate 250 mg per tsp. (5 mL)

Purpose

Carminative

Use

For the temporary relief of upset stomach or sour stomach, and acid indigestion.

Warnings

Do not use if you have kidney desease.

When sing this product

Do not take more than the maximum recommended daily dose (Adults 8 tsps. - children 4 tsps.), or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

May have laxative effect.

Ask a doctor before use

If you are taking prescription drugs. Antacids may interact with certain prescription drugs.

Keep out of reach of children.

In the case of accidental overdose, seek professional assistance or contact a Poison Control center immediately.

Directions

(Shake well before using)

Follow dosage below or as directed by a doctor.

Adults and children 12 yrs. and older: 2 tsps. every 3 to 4 hrs.

Children under 12 yrs. of age: consult a doctor before use.

Inactive ingredients

Alcohol 5%, Asafetida, Avicel, Benzyl Alcohol, Carrageenan, Glycerin, Microcrystalline Cellulose and Carboxymethylcelloulose Sodium, Purified Water, Simethicone, Sucrose, Xanthan Gum

Labels

Old

New Label

Dewees New

New

HUMCO DEWEES CARMINATIVE
magnesium carbonate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0395-0713
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARRAGEENAN (UNII: 5C69YCD2YJ)
DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S) (UNII: 83D19O7250)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ASAFETIDA (UNII: W9FZA51AS1)
GLYCERIN (UNII: PDC6A3C0OX)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0395-0713-92	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M001	03/25/1998

Labeler - Humco Holding Group, inc. (825672884)

Registrant - Pharma Nobis, LLC (118564114)

Name	Address	ID/FEI	Business Operations
Establishment
Pharma Nobis, LLC		118564114	manufacture(0395-0713) , analysis(0395-0713) , pack(0395-0713) , label(0395-0713)

Humco Dewee's Carminative