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Cold and Flu DayTime by Safeway, Inc.

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Safeway, Inc.
NDC Code: 21130-868

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 softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses
  • temporarily relieves common cold and flu symptoms:
    • minor aches & pains
    • headache
    • sore throat
    • nasal congestion
    • fever 
    • 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

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 is 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 or pharmacist before taking this product.

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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • nervousness, dizziness or sleeplessness occur
  • fever gets worse or last 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 serious liver damage.In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and 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 4 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_ 30oC (59-86oF)
  • avoid excessive heat

Inactive ingredients

butylated hydroxyanisole, butylated hydroxytoluene, carminic acid*, D&C yellow # 10 edible white ink, FD&C Red #40*, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sodium metabisulfite sorbitan, sorbitol

*may contain this ingredient

Questions or comments?

Call 1-888-723-3929 Monday- Friday 9AM- 6PM PST

Principal Display Panel

COMPARE TO Vicks® DayQuil® LiquiCaps® active ingredients†

Non-Drowsy

Daytime

Cold & Flu Relief 

Acetaminophen 325mg- Pain Reliever-Fever Reducer

Dextromethorphan HBr 10 mg - Cough Suppressant

Phenylephrine HCI 5mg - Nasal Decongestant

  • Alcohol free
  • Antihistamine free

SOFTGELS**

(**Liquid-filled capsules)

†This product is not manufactured or distributed by The Procter & Gamble Company, Vicks®, DayQuil®, 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

www.betterlivingbrandsLLC.com

Product Label

SIGNATURE CARE Non-Drowsy Daytime Cold & Flu Relief

COLD AND FLU  DAYTIME
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-868
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
BUTYLATED HYDROXYTOLUENE 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
CARMINIC ACID 
D&C YELLOW NO. 10 
SODIUM METABISULFITE 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize19mm
FlavorImprint CodeP19;95A;512;P119
Contains    
Packaging
#Item CodePackage Description
1NDC:21130-868-2424 BLISTER PACK in 1 CARTON
11 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2NDC:21130-868-3636 BLISTER PACK in 1 CARTON
21 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/31/2016
Labeler - Safeway, Inc. (009137209)

 
Safeway, Inc.

← See all Cold and Flu DayTime brands

Medically reviewed on Aug 1, 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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