SAFEWAY DAYTIME COLD AND FLU RELIEF- acetaminohpen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled 
Safeway, Inc.

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.

----------

Safeway Daytime Cold and Flu Relief

Active Ingredients (in each softgel)

Acetaminophen 325mg USP

Dextromethoprhan Hydrobromide 10mg

Phenlyephrine HCl 5mg


Purpose

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever

Warnings

 Liver warning: This product contain acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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, see 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 Parkinsons's disease),or for 2 weeks after stoping 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
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (nucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

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

  • you get nervous, dizzy, or sleepless
  • symptoms get worse or last more than 5 days(children) or 7 days (adults)
  • 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 a 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 directed can cauuse serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical atention is critical for adults and for children even if you do not notice any signs or symptoms.

Directions

  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hours

adults and children 12 years and overswallow 2 softgels with water every 4 hours 
children 4 to under 12 years ask a doctor 
children under 4 years do not use 
  • when using other Day Time or Night Time products, carefully read each label to insure correct dosing.

Other information

  • store at room temperature 15 to 30 degrees C (59-86degrees F) and avoid excessive heat
  • this product does not contain phelylpropanolamine (PPA)
  • *This product is not manufactured or distributed by Procter and Gamble, owner of the registered trademark Vicks(r) DayQuil(r)

Inactive Ingredients

butylated hydroxyanisole, butylated hydroxytoluene*, edible white printing ink, FDandC Red No. 40*, FDandC yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol.

*may contain this ingredient

Questions or comments?

Call 1-888-SAFEWAY Monday-Friday 7AM-6PM PST 

Principal Display Panel

 Compare to Vicks® DayQuil® LiquiCaps® active ingredients*

Non-Drowsy

Daytime Cold & Flu Relief

Acetaminophen,

Dextromethorphan HBr, Phenylephrine HCI

Multi-Symptom

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant
  • Nasal Decongestant

Alcohol Free

Antihistamine Free

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vick® DayQuil® LiquiCaps®.

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE.

USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY SAFEWAY INC., P.O. BOX 99

PLEASANTON, CA 94566-0009

1-888SAFEWAY / www.safeway.com

Product Labeling

day time liquid caps
SAFEWAY DAYTIME COLD AND FLU RELIEF 
acetaminohpen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-470
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
POVIDONES (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorORANGE (Orange) Scoreno score
ShapeCAPSULE (Oblong) Size20mm
FlavorImprint Code 36A;95A;P19
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-470-242 in 1 BOX
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/08/201212/31/2016
Labeler - Safeway, Inc. (009137209)

Revised: 3/2016
 
Safeway, Inc.