Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Severe Nighttime Cold And Flu Relief (NDC 11822-0677). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
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.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
ask a health professional before use.
In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid,
talc, titanium dioxide
1-800-426-9391
*Compare to the active ingredients in
Vicks® NyQuil® Severe Cold & Flu
Maximum Strenght
SEVERE NIGHTTIME
COLD & FLU RELIEF
ACETAMINOPHEN
DEXTROMETHORPHAN HBr
DOXYLAMINE SUCCINATE • PHENYLEPHRINE HCl
PAIN RELIEVER / FEVER REDUCER
COUGH SUPPRESSANT • ANTIHISTAMINE • NASAL DECONGESTANT
Relieves headache, fever, sore throat,
minor aches & pains, nasal/sinus congestion
& sinus pressure, sneezing, runny nose, cough
Actual Size
24 CAPLETS
RITE
AID®
PHARMACY
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by The Proctor & Gamble Company,
owner of the registered trademark Vicks® NyQuil® Severe Cold & Flu.
50844 ORG051967708
DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.com
SATISFACTION
GUARANTEE
If you're not satisfied,
we'll happily refund your money.
* Please review the disclaimer below.