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  5. Label Information: Tussin Expectorant

FDA Label for Tussin Expectorant

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - WHEN USING
    6. OTC - STOP USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. OTHER SAFETY INFORMATION
    11. INACTIVE INGREDIENT
    12. OTC - QUESTIONS
    13. PACKAGE LABEL

Tussin Expectorant Product Label

The following document was submitted to the FDA by the labeler of this product Aptapharma, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Drug Facts


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


Otc - 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


Otc - When Using



When using this product
■ do not use more than directed


Otc - 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.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast·feeding, ask ahealth
professional before use.


Otc - 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 20-2SoC (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


Otc - 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


* Please review the disclaimer below.