TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM- dextromethorphan hydrobromide liquid

TUSSIN COUGH by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredients (in each 5mL tsp)
Dextromethorphan HBr, USP 10mg 
Guaifenesin, USP 100mg

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 aprescription monoamine
oxidase inhibitor (MAOI) (certain drugs for
depression, psychiatric or emotional conditions, or
Parkinson's disease) or for 2 weeks atter stopping
the MAOI drug. If you do not know if your
prescription drug contains a MAOI, ask adoctor or
pharmacist before using this product.

ASK DOCTOR

Ask a doctor before use if you have
■ cough that occurs with too much phlegm (mucus)
■ cough that lasts or 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 ahealth
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.

------------------------------------------------------------------------

 Age                                       Dose
------------------------------------------------------------------------
Adults and children                 2 teaspoonfuls
12 years and over                    every 4 hours
------------------------------------------------------------------------
children under 12 years          do not use
_________________________________________

OTHER SAFETY INFORMATION

Other information

■ store at 20-25°C (68-77°F) ■ do not refrigerate
■ dosage cup provided ■ sodium 3 mg per
   teaspoonful
■ Keep carton for full directions for use.

INACTIVE INGREDIENT

Inactive ingredientsAnhydrous citric acid,
dextrose, FD&C red #40, flavor, glycerin, high
fructose corn syrup, menthol, purified water.
saccharin sodium, sodium benzoate.

Package Label

AP SAFE  NDC: 76281-503-24

COMPARE TO THE ACTIVE
INGREDIENTS IN ROBlTUSSIN®
PEAK COLD COUGH & CHEST
CONGESTION DM*

Adult
Tussin
Cough

Dextromethorphan HBr / Guaifenesin

Cough Suppressant / Expectorant

Non-Drowsy
Cough Formula

Controls Cough
Helps Loosen chest
   congestion
For Ages 12 and over

DM

4 FL OZ (118 mL)

CAUTION: DO NOT USE IF IMPRINTED SEAL UNDER
CAP IS BROKEN OR MISSING.

3
1013430
3/20

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

Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110

AP-BX-02

Carton

Bottle

res

INGREDIENTS AND APPEARANCE

TUSSIN COUGH  EXPECTORANT COUGH SUPRESSANT DM
dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-503
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	FRUIT PUNCH	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76281-503-24	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/30/2020

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(76281-503)