ADULT TUSSIN COUGH AND CHEST CONGESTION DM- dextromethorphan hbr, guaifenesin liquid
Akron Pharma Inc.

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Drug Facts

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

4oz

8oz

16oz

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	Marketing End Date
Packaging
1	NDC:71399-1004-4	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2022	01/17/2024
2	NDC:71399-1004-8	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2022	01/17/2024
3	NDC:71399-1004-6	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2022	01/17/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	11/11/2022	01/17/2024

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: 1/2024

Document Id: 8b5c5f69-3ad2-44d0-ae85-599b22f4b900

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

Version: 2

Effective Time: 20240118

Akron Pharma Inc.