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Cold Flu and Sore Throat Relief Maximum Strength

Dosage form: liquid
Ingredients: ACETAMINOPHEN 650mg in 20mL, DEXTROMETHORPHAN HYDROBROMIDE 20mg in 20mL, GUAIFENESIN 400mg in 20mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 20mL
Labeler: Safeway, Inc.
NDC Code: 21130-036

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.

Drug Facts

Active ingredients (in each 20 mL)

Acetaminophen 650 mg 

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer 

Cough suppressant

Expectorant

Nasal decongestant

Uses
  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • headache
    • sinus congestion and pressure
    • sore throat
    • cough due to minor throat and bronchial irritation
    • minor aches and pains
    • temporarily reduces fever
    • temporarily promotes nasal and/or sinus drainage
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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 daily while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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
  • for children under 12 years of age
  • 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 or pharmacist before taking this product.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have
  • diabetes
  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

 taking the blood thinning drug warfarin.

When using this product,

do not use more than directed.

Stop use and ask a doctor if
  • redness or swelling is present
  • nervousness, dizziness or sleeplessness occur
  • new symptoms occur
  • pain, nasal congestion or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • 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 (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 6 doses in a 24-hour period
  • measure only with dosing cup provided.Do not use any other dosing device. 
  • keep dosing cup with product
  • dose as follows or as directed by a doctor
  • mL = milliliter
  • adults and children 12 years of age and older: 20 mL every 4 hours while symptoms last 
  • children under 12 years of age: do not use

Other information
  • each 20 mL contains: sodium 12 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions or comments?

 Call1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

AGES 12 & OVER 

Maximum Strength

Cold, Flu & Sore Throat Relief

Acetaminophen 650 mg

-Pain Reliever - Fever Reducer

Dextromethorphan HBr 20 mg

-Cough Suppressant

Guaifenesin 400 mg

-Expectorant

Phenylephrine HCl 10 mg

-Nasal Decongestant

Relief of: fever, aches, cough, stuffy nose, mucus & chest congestion

Compare to Maximum strength Mucinex®Fast-Max® Cold, Flu & Sore Throat active ingredients*

FL OZ (mL)

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore Throat.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

www.betterlivingbrandsLLC.com

Package Label

SIGNATURE CARE Maximum Strength Cold, Flu & Sore Throat Relief

COLD FLU AND SORE THROAT RELIEF  MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-036
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
DISODIUM EDTA-COPPER 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
PROPYL GALLATE 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBITOL 
SUCRALOSE 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:21130-036-06177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/2014
Labeler - Safeway, Inc. (009137209)

 
Safeway, Inc.

Medically reviewed on Mar 2, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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