TUSSIN DM- dextromethorphan hbr, guaifenesin liquid

Tussin DM by

Drug Labeling and Warnings

Tussin DM by is a Otc medication manufactured, distributed, or labeled by AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP     20 mg

Guaifenesin, USP                      200 mg

PURPOSE

Purpose

Dextromethorphan HBr, USP           Cough suppressant
Guaifenesin, USP                              Expectorant

INDICATIONS & USAGE

Uses
Temporarily relieves cough due to minor throat and bronchial
   irritation as may occur with acold
helps loosen phlegm (mucus) and thin bronchial secretions to
  drain bronchial tubes

WARNINGS

Warnings
Do not use: in a child under 12 years of age 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 DOCTOR

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

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  In case of overdose, get medical
help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

do not take more than 6 doses in any 24-hour period
mL = milliliter

• Age: Dose
• Adults & children 12 years & over: 10 mL every 4 hours
• Children under 12 years: Do not use

OTHER SAFETY INFORMATION

Other information
store at 20-25oC (68-77oF)
do not refrigerate
dosage cup provided
each 10 mL contains: sodium 3 mg

INACTIVE INGREDIENT

Inactive ingredients

Anhydrous citric acid, flavor, purified water,
sodium benzoate, sucrose

QUESTIONS

Ouestions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Principal Display Panel

CVS
HealthTM

Compare to the active
ingredients in Robitussin® Peak
Cold Cough & Chest Congestion*

MAXIMUM STRENGTH

Non-Drowsy
Tussin DM
ADULT COUGH &
CHEST CONGESTION

Free of alcohol, dyes &
artificial sweeteners

DEXTROMETHORPHAN HBr
Cough suppressant

GUAIFENESIN
Expectorant

Relieves:
Cough
Chest Congestion

For Ages
12 & Over

Cherry Flavor

8 FL OZ (237 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences

DO NOT REFRIGERATE. STORE AT ROOM TEMPERATURE.

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

Lot:
Exp:

LR-108 REV 01 #339107

0 50428 61311 5

CONTINUED →
ON BACK

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-34690

√CVS Quality
Money Back Guarantee

↓Product Package↓

                               Tussin DM by CVS Pharmacy, Inc.

res

INGREDIENTS AND APPEARANCE

TUSSIN DM 
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-310
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)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76281-310-26	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/01/2018

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(76281-310)