PREMIER VALUE MAXIMUM STRENGTH- dextromethorphan hbr, guaifenesin solution

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Drug Labeling and Warnings

Premier Value by is a Otc medication manufactured, distributed, or labeled by PHARMACY VALUE ALLIANCE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• shake well before using
• 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.
• Alcohol-free

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® COUGH + CONGESTION DM

NDC# 68016-740-04

Maximum Strength for MUSCUS RELIEF

Tussin DM Max

Cough Suppressant, Dextromethorphan HBr

Expectorant, Guaifenesin

• Relieves Chest Congestion
• Controls cough and mucus

Non-Drowsy

For Ages 12 & Over

4 FL OZ (118 mL)

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

INGREDIENTS AND APPEARANCE

PREMIER VALUE  MAXIMUM STRENGTH
dextromethorphan hbr, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-740
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 FORM (UNII: K679OBS311)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-740-04	1 in 1 CARTON	03/25/2019
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 final	part341	03/25/2019

Labeler - PHARMACY VALUE ALLIANCE LLC (101668460)