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

Tussin DM Cough and Chest Congestion by

Drug Labeling and Warnings

Tussin DM Cough and Chest Congestion by is a Otc medication manufactured, distributed, or labeled by P & L Development, LLC. 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 (1-800-222-1222) right away.

Directions

• do not take more than 6 doses in any 24-hour period
• measure only with the dosing cup provided. do not use any other dosing device
• 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

• store between 20-25ºC(68-77ºF). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, FD&C red 40, flavor, glucose, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients of Robitussin® Peak Cold Cough + Chest Congestion DM*

adult

Tussin DM Cough + Chest Congestion

Dextromethorphan HBr 20 mg

Cough Suppressant

Guaifenesin 200 mg

Expectorant

Relieves:

• Cough
• Mucus

for ages 12 years and over

Non-Drowsy

alcohol free

Dosing Cup Included

FL OZ (mL)

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Peak Cold Cough + Chest Congestion DM.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

Package Label

READYinCASE Adult Tussin DM Cough + Chest Congestion

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49580-0385
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
DEXTROSE (UNII: IY9XDZ35W2)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49580-0385-4	1 in 1 BOX	03/31/2015
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 49580-0385-8	1 in 1 BOX	03/31/2015
2		237 mL in 1 BOTTLE, PLASTIC; 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	03/31/2015

Labeler - P & L Development, LLC (101896231)