Active Ingredients (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
The following Structured Product Label (SPL) was submitted to the FDA by Salado Sales Inc. for the product Nighttime Cold And Flu Relief (NDC 57243-603). 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 softgel), 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 15 mg
Doxylamine succinate 6.25 mg
Pain reliever/Fever reducer
Cough suppressant
Antihistamine
temporarily relieves common cold/flu symptoms:
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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
■ liver disease ■ glaucoma
■ cough that occurs with too much phlegm (mucus)
■ a breathing problem or chronic cough that lasts or as occurs
with smoking, asthma, chronic bronchitis or emphysema
■ trouble urinating due to enlarged prostate gland
These could be signs of a serious condition.
ask a health professional before use.
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
| adults & children 12 yrs & over | 2 softgels with water every 6 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
■ when using other Daytime or Nighttime products,
carefully read each label to ensure correct dosing
D&C yellow no. 10, FD&C blue no. 1, Gelatin, Glycerin, Polyethylene glycol, povidone, Propylene glycol, Purified water, Sorbitol sorbitan solution, Titanium dioxide
Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
CVP COMPARE TO VICKS® NYQUIL™
HEALTH COLD & FLU LIQUICAPS™
NIGHT TIME ACTIVE INGREDIENTS
SOFTGELS
MULTI-SYMPTOM COLD & FLU MEDICINE RELIEVES:
• ACETAMINOPHEN-PAIN RELIEVER/FEVER REDUCER HEADACHE
• DEXTROMETHORPHAN HBr- COUGH SUPPRESSANT FEVER
• DOXYLAMINE SUCCINATE- ANTIHISTAMINE SORE THROAT
MINOR ACHES & PAINS
24 SOFTGELS SNEEZING
RUNNY NOSE
COUGH
Distributed by Consumer Value Products, Inc.
P.O. Box 6115, Temple, Texas 76502
CVPproducts.com
*This product is not manufactured or distributed by Procter &
Gamble, owner of the registered trademark Vicks® NyQuil™
LiquiCaps™
RES
* Please review the disclaimer below.