ADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE- dextromethorphan hbr, guaifenesin liquid

Adult Tussin Cough and Chest Congestion DM Sugar Free by

Drug Labeling and Warnings

Adult Tussin Cough and Chest Congestion DM Sugar Free by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP., UNIT DOSE SOLUTIONS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
• 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
• adults and children 12 years and over: 10 mL every 4 hours
• children under 12 years: do not use

Other information

• Phenylketonurics: contains Phenylalanine 30 mg per 10 mL
• store between 20-25ºC(68-77ºF). Do not refrigerate

Inactive ingredients

acesulfame potassium, citric acid, flavor cherry, glycerin, menthol crystals, purified water, sorbitol solution 70%, sodium citrate, sodium saccharin, sodium benzoate.

Questions or comments?

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP

MIAMI, FL 33179

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE 
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-1006(NDC:71399-1006)
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 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-1006-1	72 in 1 BOX, UNIT-DOSE	11/17/2022
1	NDC: 17856-1006-3	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 17856-1006-2	72 in 1 BOX, UNIT-DOSE	11/17/2022
2	NDC: 17856-1006-4	10 mL in 1 CUP, UNIT-DOSE; 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	11/11/2022

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
UNIT DOSE SOLUTIONS		360804194	repack(17856-1006)