Label: GERI-TUSSIN EXPECTORANT - guaifenesin liquid
- NDC Code(s): 57896-793-16
- Packager: Geri-Care Pharmaceuticals, Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated June 3, 2013
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- Active ingredient (per teaspoonful = 5mL)
Guaifenesin, USP 100 mgClose
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productiveClose
Do not use if you are hypersensitive to any of the ingredients
Ask a doctor before use if you have
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- do not take more than 6 doses in any 24-hour period
- do not exceed recommended dose
adults and children 12 years and over
2-4 teaspoonfuls every 4 hours
children under 12 years
ask a doctor
- Other information
• store at room temperature 15º - 30ºC (59º - 86ºF)
• protect from freezing
• protect from light
• TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSINGClose
- Inactive ingredients
citric acid, caramel, FD and C Red 40, flavor, glycerin, menthol, sodium saccharin, sodium benzoate, sorbitol, waterClose
- package Label
loosens and relieves chest congestion
compare to the active ingredient of Robitussin
16 FL OZ (473 mL)
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-793 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARAMEL (UNII: T9D99G2B1R) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-793-16 473 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2000 Labeler - Geri-Care Pharmaceuticals, Corp (611196254)