Active Ingredients (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg
Cold And Flu Relief Capsule, Liquid Filled
FDA Label NDC 21130-849
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway, Inc. for the product Cold And Flu Relief (NDC 21130-849). 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 of 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.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistimine
Pain reliever / fever reducer
Cough suppressant
Antihistamine
Uses
- temporarily relieves common cold and flu symptoms:
- sore throat
- headache
- minor aches and pains
- fever
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- 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
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.
Do Not Use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor of pharmacist before taking this product.
Ask A Doctor Before Use If You Have
- liver disease
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem or chronic cough that such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Ask A Doctor Of Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When Using This Product
- do not exceed recommended dosage
- excitability may occur, especially in children
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- pain or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1888-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 4 doses in 24 hours
- adults and children 12 years and over: take 2 softgels with water every 6 hours
- swallow whole; do not crush, chew, or dissolve
- children under 12 years: do not use
- when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
Other Information
- store between 15-30°C (59-86°F)
- avoid excessive heat
Inactive Ingredients
D&C yellow #10, FD&C blue #1, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink
Questions Or Comments?
Call 1-888-723-3929 Monday-Friday 7AM-6PM PST
Principal Display Panel
COMPARE TO Vick® NyQuil® LiquiCaps® active ingredients†
Nighttime Cold & Flu Relief
ACETAMINOPHEN 325 mg - Pain Reliever / Fever Reducer
DEXTROMETHORPHAN HBr 15 mg - Cough Suppressant
DOXYLAMINE SUCCINATE 6.25 mg - Antihistamine
Relieves
- Aches, Fever, SoreThroat
- Cough
- Runny Nose, Sneezing
Alcohol-Free
SOFTGELS**
(**Liquid-Filled Capsules)
†This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, NyQuil®, and LiquiCaps® are registered trademarks of The Procter & Gamble Company
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
Package Label
SIGNATURE CARE Nighttime Cold & Flu Relief
* Please review the disclaimer below.
