FDA Label for G Tussin Ac

View Indications, Usage & Precautions

G Tussin Ac Product Label

The following document was submitted to the FDA by the labeler of this product The Generic Pharmaceutical Company. 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.

Other



Drug Facts


Otc - Purpose



Active ingredients
(in each 5 mL = 1 tsp)
Purpose
Codeine phosphate, USP 10 mgAntitussive
Guaifenesin, USP 100 mgExpectorant

Uses



  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
    • your cough to help you sleep
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Ask Your Doctor Before Use If



  • you have a persistent cough, this may be a sign of a serious condition
  • you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • you have a cough that is accompanied by excessive phlegm (mucus)
  • you have chronic pulmonary disease or shortness of breath
  • giving to a child who is taking other drugs

When Using This Product



  • giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.
  • may cause or aggravate constipation

Stop Use And Ask A Doctor If



  • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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


Directions



  • do not exceed 6 doses in 24 hours.
  • Adults and children 12 years of age and over:2 tsp (10 mL) every 4 hours, or as directed by a doctor.
    Children 6 to under 12 years of age:1 tsp (5 mL) every 4 hours, or as directed by a doctor.
    Children under 6 years of age:Consult a doctor.

Other Information



Store at controlled room temperature 15°-30°C (59°-86°F).


Question? Comments?



Call 1-205-313-8298


Inactive Ingredients



Cherry flavor, citric acid, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose.


Principal Display Panel - 473 Ml Bottle Label



NDC: 57963-103-16

G Tussin AC
Antitussive/Expectorant

• Sugar Free • Alcohol Free
• Dye Free • Gluten Free

Each 5 mL (1 teaspoonful) contains:
Codeine phosphate, USP 10 mg
Guaifenesin, USP 100 mg

Caution: For manufacturing, processing,
or repackaging. This is a bulk container;
not intended for household use.

Tamper evident by
foil seal under cap.
Do not use if foil seal
is broken or missing.

Manufactured for:
The Generic Pharmaceutical Company, Inc.
Leeds, AL 35094

16 fl. oz. (473 mL)


* Please review the disclaimer below.