PREMIER VALUE- dextromethorphan hbr, guaifenesin solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)
Available from:
PHARMACY VALUE ALLIANCE LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Cough suppressant Expectorant 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. 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.
Authorization status:
OTC monograph final
Authorization number:
68016-744-04

PREMIER VALUE- dextromethorphan hbr, guaifenesin solution

PHARMACY VALUE ALLIANCE LLC

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.

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Premier Value Sugar Free Tussin DM Drug Facts

Active ingredients (in each 20 mL)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Purpos es

Cough suppressant

Expectorant

Us es

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

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.

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

cough that occurs with too much phlegm (mucus)

cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or

emphysema

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

dose

adults and children 12 years and over

20 mL every 4 hours

children under 12 years

do not use

Other information

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Red No. 40, flavor, potassium citrate, propylene glycol,

purified water, 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® Sugar Free Cough + Congestion DM

NDC# 68016-744-04

Premier Value

Sugar Free

Tussin DM

Cough Suppressant

Dextromethorphan HBr

Expectorant

Guaifenesin

Specially Formulated for DIABETICS

Non-Drows y

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

store at room temperature. Do not refrigerate.

Alcohol-free

Relieves Chest Congestion

Controls cough and mucus

For Ages 12 & Over

4 FL OZ (118 mL)

IMPORTANT: Keep this carton for future reference on full labeling.

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

*This product is not manufactured or distributed by Pfizer, owner of the registered trademark

Robitussin Sugar Free Cough + Congestion DM.

PREMIER VALUE

dextromethorphan hbr, guaifenesin solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 0 16 -744

Route of Administration

ORAL

Active Ingredient/Active Moiety

PHARMACY VALUE ALLIANCE LLC

Ingredient Name

Basis of Strength

Stre ng th

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

20 mg

in 20 mL

GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ)

GUAIFENESIN

20 0 mg

in 20 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

PO TASSIUM CITRATE (UNII: EE9 0 ONI6 FF)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 0 16 -744-0 4

1 in 1 CARTON

0 3/20 /20 19

1

118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 3/20 /20 19

Labeler -

PHARMACY VALUE ALLIANCE LLC (101668460)

Revised: 9/2020

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