Country: United States
Language: English
Source: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Humana Pharmacy, Inc.
ACETAMINOPHEN
ACETAMINOPHEN 325 mg
ORAL
OTC DRUG
Pain reliever/fever reducer Nasal decongestant
OTC monograph final
HUMANA PHARMACY SINUS RELIEF- ACETAMINOPHEN, PHENYLEPHRINE HCL TABLET, FILM COATED HUMANA PHARMACY, INC. _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._ ---------- HUMANA PHARMACY, INC. SINUS RELIEF DRUG FACTS ACTIVE INGREDIENTS (IN EACH CAPLET) Acetaminophen 325 mg Phenylephrine HCl 5 mg PURPOS E Pain reliever/fever reducer Nasal decongestant US ES • • • • • • • • • WARNINGS Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • • • Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • • • If a skin reaction occurs, stop use and seek medical help right away. DO NOT USE temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: headache sinus congestion and pressure nasal congestion minor aches and pains helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages temporarily reduces fever more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product skin reddening blisters rash • • • ASK A DOCTOR BEFORE USE IF YOU HAVE • • • • • • ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking the blood thinning drug warfarin WHEN USING THIS PRODUCT do not exceed recommended dosage STOP USE AND ASK A DOCTOR IF • • • • • IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. DIRECTIONS • adults and children 12 years and over • • with any other drug containing acetamin Read the complete document