Label: GUAIFENESIN- guaifenesin tablet
- NDC Code(s): 42291-313-01
- Packager: AvKARE, Inc.
- 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 April 24, 2019
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- Active ingredient (in each immediate-release tablet)
Guaifenesin 200 mgClose
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productiveClose
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
Stop use and ask a doctor if
cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- do not exceed 6 doses in 24 hours
- take with a full glass of water
adults and children 12 years
of age and over
1 to 2 tablets every
children 6 to under 12 years
½ to 1 tablet every
children under 6 years of age consult a physician
- Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- use by expiration date on package
- Inactive ingredients
FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acidClose
- Questions or comments?1-855-361-3993
- Principal Display Panel
Relieves Chest Congestion
Thins and Loosens Mucus
Distributed by AvKARE
Pulaski, TN 38478 AV 10/13
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42291-313 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength POVIDONE (UNII: FZ989GH94E) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color pink (dark) Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;588 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42291-313-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/04/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/04/2013 Labeler - AvKARE, Inc. (796560394)