G Tussin AC: Package Insert and Label Information

G TUSSIN AC- codeine phosphate and guaifenesin liquid
The Generic Pharmaceutical Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients (in each 5 mL = 1 tsp) Purpose
Codeine phosphate, USP 10 mg Antitussive
Guaifenesin, USP 100 mg Expectorant

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.

Warnings

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.

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

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)

Principal Display Panel -- 473 mL Bottle Label
(click image for full-size original)
G TUSSIN AC
codeine phosphate and guaifenesin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57963-103
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 10 mg in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
Methylparaben
Potassium Citrate
Potassium Sorbate
Propylparaben
Propylene Glycol
Water
Sorbitol
Sucralose
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57963-103-16 473 mL in 1 BOTTLE, PLASTIC None
2 NDC:57963-103-04 118 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 12/01/2016
Labeler — The Generic Pharmaceutical Company (078787060)

Revised: 01/2021 The Generic Pharmaceutical Company

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