ADULT COUGH PLUS CHEST CONGESTION DM WITH HONEY- dextromethorphan hbr, guaifenesin solution

Adult Cough plus Chest Congestion DM by

Drug Labeling and Warnings

Adult Cough plus Chest Congestion DM by is a Otc medication manufactured, distributed, or labeled by WALGREEN COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 20 ml)	Purposes
Dextromethorphan HBr, USP 20 mg	Cough suppressant
Guaifenesin, USP 400 mg	Expectorant

INDICATIONS & USAGE

Uses

• ▪ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• ▪ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

WARNINGS

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• ▪ cough that occurs with too much phlegm (mucus)
• ▪ cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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 at 1-800-222-1222.

DOSAGE & ADMINISTRATION

Directions

• ▪ do not take more than 6 doses in any 24-hour period
• ▪ measure only with dosing cup provided
• ▪ keep dosing cup with product
• ▪ ml = milliliter
• ▪ this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	20 ml every 4 hours
children under 12 years	do not use

STORAGE AND HANDLING

Other information

• ▪ each 20 ml contains: sodium 10 mg
• ▪ store at room temperature. Do not refrigerate.

INACTIVE INGREDIENT

Inactive ingredients

citric acid, carboxymethylcellulose sodium, edetate disodium, glycerin, honey, natural & artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum, zinc gluconate

QUESTIONS

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

Compare to active ingredients in Robitussin® Honey Cough + Chest Congestion DM MAX*

NDC: 0363-7754-04

Adult

Cough + Chest

Congestion DM

With Honey

Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)

Maximum Strength

DM MAX

• Controls Cough
• Relieves Chest Congestion
• Thins & Loosens Mucus
• Gluten Free
• No Artificial Colors
• No Added Alcohol

Taste the Real Honey

For Ages 12 & Over

4 FL OZ (118 ml)

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Adult Robitussin® Honey Cough + Chest Congestion DM MAX.

TAMPER EVIDENT: DON NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

IMPORTANT: Keep this carton for future reference for full labelling.

Distributed by:

INGREDIENTS AND APPEARANCE

ADULT COUGH PLUS CHEST CONGESTION DM  WITH HONEY
dextromethorphan hbr, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-7754
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
HONEY (UNII: Y9H1V576FH)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-7754-04	1 in 1 CARTON	02/05/2024
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	02/05/2024

Labeler - WALGREEN COMPANY (008965063)