Country: United States
Language: English
Source: NLM (National Library of Medicine)
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)
Ulai Health LLC
ORAL
OTC DRUG
Expectorant - helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus - helps make cough more productive - persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema - cough accompanied by too much phlegm (mucus) - cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be sings of a serious illness.
OTC monograph final
PHARBINEX- GUAIFENESIN 400MG TABLET ULAI HEALTH LLC _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 FACTS ACTIVE INGREDIENT (IN EACH TABLET) Guaifenesin 400 mg PURPOSE Expectorant USES helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus helps make cough more productive 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 sings of a serious illness. 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 (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 a 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 ask a doctor OTHER INFORMATION store at 20 - 25 C (68 -77 F) INACTIVE INGREDIENTS magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, stearic acid QUESTIONS? (866) 562-2756 (Mon-Fri 8 AM to 4 PM EST) TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of registered trademark Mucinex Distributed by: ULAI HEALTH LLC. Alexandria, VA 22312 PHARBEST NDC 73057-379-04 MANUFACTURED IN THE USA _IMMEDIATE RELEASE_ PHARBINEX *COMPARE TO THE ACTIVE INGREDIENT IN MUCINEX TABLETS GUAIFENESIN 400 Read the complete document