TUSSIN EXPECTORANT- guaifenesin liquid

Tussin Expectorant by

Drug Labeling and Warnings

Tussin Expectorant 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 ingredient (in each 5 mL teaspoon)
Guaifenesin, USP ........ 100 mg

PURPOSE

Purpose
Expectorant

INDICATIONS & USAGE

Uses
■ Helps loosen phlegm (mucus) and thin bronchial
   secretions to rid the bronchial passageways of
   bothersome mucus and make coughs more
   productive

WARNINGS

Warnings

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

WHEN USING

When using this product
■ do not use more than directed

STOP USE

Stop use and ask a doctor if
■ cough lasts more than 7 days, comes back, or
   occurs with 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 medicai 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 12 years and over:

  2-4 teaspoonfuls

  every 4 hours

• Children under 12 years: do not use

OTHER SAFETY INFORMATION

Other information
■ each 5 mL contains: sodium 3 mg
■ store between 20-2S oC (68-77°F)
■ do not refrigerate
■ dosing cup provided
■ Keep carton for full directions for use

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

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

Package Label

AP SAFE                                  NDC: 76281-507-24

*COMPARE TO THE ACTIVE
INGREDIENT IN ROBITUSSIN ®
MUCUS+CHEST CONGESTION.

Adult
Tussin
Expectorant

Guaifenesin
Oral Solution, USP
Non-Drowsy

Relieves Chest Congestion
Loosens Mucus
For ages 12 & Over

4 FL OZ (118 mL)

DO NOT USE IF PRINTED SEAL UNDER CAP IS
TORN OR MISSING

AP-BX-04

*This product is not manutactured or distributed by
Pfizer, the distributor of Robitussin ®Mucus plus
Chest Congestion.

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

Carton

Bottle

res

INGREDIENTS AND APPEARANCE

TUSSIN EXPECTORANT 
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-507
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CARAMEL (UNII: T9D99G2B1R)
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	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76281-507-24	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)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma, Inc.		790523323	manufacture(76281-507)