Label: GUAIFENESIN- guaifenesin tablet
- NDC Code(s): 0904-5154-60
- Packager: Major Pharmaceuticals
- 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 November 7, 2018
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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?
(800) 616-2471 Close
- Principal Display Panel
Guaifenesin 200 mg
- Relieves Chest Congestion
- Thins and Loosens Mucus
Distributed by MAJOR® PHARMACEUTICALS
31778 Enterprise Drive, Livonia, MI 48150 USA
Re-Order No. 238163 M-17 Rev. 04/13
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:0904-5154 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 MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) FD&C RED NO. 40 (UNII: WZB9127XOA) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color PINK (dark) Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 44;588 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-5154-60 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/05/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 10/05/2009 Labeler - Major Pharmaceuticals (191427277) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(0904-5154) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(0904-5154) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(0904-5154) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(0904-5154)