G Tussin Ac

G Tussin Ac
SPL v4
SPL
SPL Set ID b6fd0428-30d0-4abf-bb23-76c2dd9d7c92
Route
ORAL
Published
Effective Date 2021-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Codeine Anhydrous (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Citric Acid Monohydrate Methylparaben Potassium Citrate Potassium Sorbate Propylparaben Propylene Glycol Water Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-12-01

Description

Drug Facts


Medication Information

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1

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

Section 53414-9

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

Section 55105-1
Active ingredients

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

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.
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
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)


Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients

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

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

Question? Comments?

Call 1-205-313-8298

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (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 (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.
Ask Your Doctor Before Use If (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
Principal Display Panel 473 Ml Bottle Label (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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)