Search by Drug Name or NDC

NDC 71399-1004-08 Adult Tussin Cough and Chest Congestion DM 20; 200 mg/10mL; mg/10mL Details

Adult Tussin Cough and Chest Congestion DM 20; 200 mg/10mL; mg/10mL

Adult Tussin Cough and Chest Congestion DM is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Akron Pharma Inc.. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.

MedlinePlus Drug Summary

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 71399-1004-08
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 71399-1004-08
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	71399-1004
Product ID	71399-1004_c36f1658-61e2-435f-a83d-66f7b4a3dc74
Associated GPIs
GCN Sequence Number	000652
GCN Sequence Number Description	guaifenesin/dextromethorphan LIQUID 100-10MG/5 ORAL
HIC3	B3T
HIC3 Description	NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION
GCN	53491
HICL Sequence Number	000223
HICL Sequence Number Description	GUAIFENESIN/DEXTROMETHORPHAN HBR
Brand/Generic	Generic
Proprietary Name	Adult Tussin Cough and Chest Congestion DM
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextromethorphan HBr, Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	20; 200
Active Ingredient Units	mg/10mL; mg/10mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Labeler Name	Akron Pharma Inc.
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Ant
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71399-1004-08 (71399100408)

Pricing Information	N/A
NDC Package Code	71399-1004-8
Billing NDC	71399100408
Package	236 mL in 1 BOTTLE, PLASTIC (71399-1004-8)
Marketing Start Date	2022-11-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0ea4968d-34d6-487a-af0d-ebdc677c22d9 Details

Active ingredients (in each 10 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 200 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 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 (1-800-222-1222).

Directions

do not take more than 6 doses in any 24-hour period
mL= milliliter
this adult product is not intended for use in children under 12 years of age
adults and children 12 years and over: 10 mL every 4 hours
children under 12 years: do not use

Other information

each 5 mL contains: sodium 2 mg
store between 20-25ºC(68-77ºF). Do not refrigerate

Inactive ingredients

citric acid, cherry flavor, glycerin, high fructose corn syrup, menthol crystals, purified water, sodium benzoate, sodium citrate, sodium saccharin,

sucrose.

Questions or comments?

1-877-225-6999

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADULT TUSSIN COUGH AND CHEST CONGESTION DM

dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71399-1004
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white (colorless)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71399-1004-4	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2022
2	NDC:71399-1004-8	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2022
3	NDC:71399-1004-6	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	11/11/2022

Labeler - Akron Pharma Inc. (067878881)

Registrant - SLV PHARMACEUTICALS LLC (081225162)

Name	Address	ID/FEI	Business Operations
Establishment
SLV PHARMACEUTICALS LLC		081225162	manufacture(71399-1004)

Revised: 11/2022

Document Id: c36f1658-61e2-435f-a83d-66f7b4a3dc74

Set id: 0ea4968d-34d6-487a-af0d-ebdc677c22d9

Version: 1

Effective Time: 20221111