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.

----------

G Tussin AC

Drug Facts

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

Uses

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

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
G TUSSIN AC 
codeine phosphate and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57963-103
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Methylparaben (UNII: A2I8C7HI9T)  
Potassium Citrate (UNII: EE90ONI6FF)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Propylparaben (UNII: Z8IX2SC1OH)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
Sucralose (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57963-103-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2016
2NDC:57963-103-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/01/2016
Labeler - The Generic Pharmaceutical Company (078787060)

Revised: 1/2021
Document Id: c1c7d7e7-f18d-491d-91f2-b968c8a35d1e
Set id: b6fd0428-30d0-4abf-bb23-76c2dd9d7c92
Version: 4
Effective Time: 20210112
 
The Generic Pharmaceutical Company