Maximum Strength Adult Cough Plus Chest Congestion DM: Package Insert and Label Information

MAXIMUM STRENGTH ADULT COUGH PLUS CHEST CONGESTION DM- dextromethorphan hydrobromide and guaifenesin solution
FAMILY DOLLAR SERVICES INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients (in each 20 mL)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Purposes

Cough suppressant

Expectorant

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

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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (1-800-222-1222).

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

Other information

each 20 mL contains: sodium 7 mg
store at room temperature. Do not refrigerate.

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C Red No. 40, flavor, menthol, microcrystalline cellulose, povidone, propylene glycol, purified water, potassium citrate, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

Questions or comments?

1-866-467-2748

Package/Label Principal Display Panel

Compare to the active ingredients of Robitussin® Maximum Strength Cough + Chest Congestion DM MAX*

NDC# 55319-740-04

Maximum Strength

Adult

Cough+Chest

Congestion DM

Dextromethorphan HBr (Cough Suppressant)

Guaifenesin (Expectorant)

Controls cough
Relieves Chest Congestion
Thins and Loosens Mucus

Sugar-Free

No Added Alcohol

Use Dosage Cup Included

Natural Raspberry Flavor

For Ages 12 & Over

4 FL OZ (118 mL)

Distributed By:

*This product is not manufactured or distributed by Pfizer, owner of the registered trademark Adult Robitussin® Maximum Strength Cough + Congestion DM MAX.

Family Dollar Max Strength Dextrometorphan HBr, Guaifenesin
(click image for full-size original)
MAXIMUM STRENGTH ADULT COUGH PLUS CHEST CONGESTION DM
dextromethorphan hbr, guaifenesin solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-740
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 400 mg in 20 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
EDETATE DISODIUM
FD&C RED NO. 40
MENTHOL, UNSPECIFIED FORM
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
WATER
POTASSIUM CITRATE
SODIUM BENZOATE
SORBITOL
SUCRALOSE
XANTHAN GUM
Product Characteristics
Color RED Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55319-740-04 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (55319-740-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 05/08/2023
Labeler — FAMILY DOLLAR SERVICES INC (024472631)

Revised: 05/2023 FAMILY DOLLAR SERVICES INC

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