Active Ingredients (In Each Packet) – Multi Symptom Severe Cold
Acetaminophen 500 mg
Dextromethorphan hydrobromide 20 mg
Phenylephrine hydrochloride 10 mg
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Multi Symptom Severe Cold And Nighttime Severe Cold And Cough (NDC 49035-948). 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 packet) – multi symptom severe cold, active ingredients (in each packet) - nighttime severe cold and cough, purpose - multi symptom severe cold, purpose - nighttime severe cold and cough, uses - multi symptom severe cold, uses - nighttime severe cold and cough, warnings – multi symptom severe cold /nighttime severe cold and cough, do not use - multi symptom severe cold, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 500 mg
Dextromethorphan hydrobromide 20 mg
Phenylephrine hydrochloride 10 mg
Acetaminophen 650 mg
Diphenhydramine hydrochloride 25 mg
Phenylephrine hydrochloride 10 mg
Pain reliever/fever reducer
Cough Suppressant
Nasal Decongestant
Pain reliever/fever reducer
Antihistamine/Cough suppressant
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.
taking the blood thinning drug warfarin
do not exceed recommended dosage
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Age | Dose |
Adults and children 12 years of age | One packet |
Children under 12 years of age | Do not use |
Age | Dose |
Adults and Children 12 years of age and over | One packet |
Children under 12 years of age | do not use |
citric acid, caramel, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose
citric acid, F D & C yellow #6 , flavors, maltodextrin, potassium chloride, silica ,sucralose, sucrose,
1-866-467-2748
NDC# 49035-948-12
DAY & NIGHT PACK
Compare to active ingredients in Theraflu® Multi Symptom Severe Cold* and Nighttime Severe Cold & Cough *
MULTI- SYMPTOM
SEVERE COLD
ACETAMINOPHEN / PAIN RELIEVER/ FEVER REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
PHENYLEPHRINE HCl / NASAL DECONGESTANT
DYE FREE
ASPARTAME FREE
SODIUM FREE
Relieves
GREEN TEA & HONEY LEMON FLAVORS
INFUSED WITH MENTHOL AND GREEN TEA FLAVOR
Naturally and Artificially Flavored
NIGHTTIME SEVERE & COLD & COUGH
ACETAMINOPHEN/ PAIN RELIEVER/ FEVER REDUCER
DIPHENHYDRAMINE HCl / ANTIHISTAMINE/ COUGH SUPPRESSANT
PHENYLEPHRINE HCl / NASAL DECONGESTANT
ASPARTAME FREE
SODIUM FREE
Relieves
HONEY LEMON FLAVOR INFUSED WITH CHAMOMILE &WHITE TEA FLAVORS
6 NIGHTTIME PACKETS
TOTAL 12 PACKETS
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE .KEEP CARTON FOR REFERENCE, DO NOT DISCARD. |
DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 –HOUR PERIOD. |
DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF DAYTIME PRODUCT UNLESS DIRECTED BY DOCTOR. |
*These Products are not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® Multi-Symptom Severe Cold & Theraflu® Nighttime Severe Cold & Cough.
Distributed By:
Wal-Mart Stores, Inc. Bentoville, AR 72716
© Wal-Mart Stores, Inc.
*This product is not manufactured or distributed by Novartis Consumer Health Inc., Owner of the registered trademark Gas-X®.
TAMPER EVIDENT INNER UNIT:DO NOT USE IF SEALED PACKET IS TORN OR BROKEN |
* Please review the disclaimer below.