![G TUSSIN AC (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [THE GENERIC PHARMACEUTICAL COMPANY]](https://medic.hrt.org//dailymed/images/b6fd0428-30d0-4abf-bb23-76c2dd9d7c92/tussin-01.jpg)
| NDC | 57963-103-04, 57963-103-16 |
| Set ID | b6fd0428-30d0-4abf-bb23-76c2dd9d7c92 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | The Generic Pharmaceutical Company |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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.
- temporarily relieves:
- 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.
CloseKeep 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.
CloseAdults 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
- Question? Comments?
- Inactive ingredients
Cherry flavor, citric acid, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose.
Close - PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
NDC: 57963-103-16
G Tussin AC
Antitussive/Expectorant• Sugar Free • Alcohol Free
• Dye Free • Gluten FreeEach 5 mL (1 teaspoonful) contains:
Codeine phosphate, USP 10 mg
Guaifenesin, USP 100 mgCaution: 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 3509416 fl. oz. (473 mL)
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- INGREDIENTS AND APPEARANCE
G TUSSIN AC
codeine phosphate and guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57963-103 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 10 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:57963-103-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2016 2 NDC:57963-103-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 12/01/2016 CloseLabeler - The Generic Pharmaceutical Company (078787060)