Label: GUAIFENESIN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 16103-379-04 - Packager: Pharbest Pharmaceuticals, 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.
Drug Label Information
Updated January 11, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Ask 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 serious illness.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
- take with a full glass of water
- this product can be administered without regard for the timing of the meals
- do not exceed 6 doses in 24 hours or as directed by doctor
adults and children 12 years of age and over
take 1 tablet every 4 hours as needed
children 6 to under 12 years of age
take ½ tablet every 4 hours as needed
children under 6 years of age
consult a doctor
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GUAIFENESIN
guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16103-379 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score 2 pieces Shape CAPSULE (CAPSULE SHAPED TABLET) Size 17mm Flavor Imprint Code PH063 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16103-379-04 1 in 1 CARTON 05/01/2018 1 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2018 Labeler - Pharbest Pharmaceuticals, Inc. (557054835) Registrant - Pharbest Pharmaceuticals, Inc. (557054835) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc. 557054835 manufacture(16103-379) , analysis(16103-379) , pack(16103-379) , label(16103-379)
