DAYTIME COLD AND FLU RELIEF NON DROWSY- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid 
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.

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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/flu symptoms:
    • minor aches and pains 
    • headache
    • sore throat
    • fever
    • nasal congestion
    • 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 6 doses (12 tablespoons or 180 mL) in 24 hours for adults
  • more than 5 doses (5 tablespoons or 75 mL) in 24 hours for children 6-12 years old
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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

  • 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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if the user has

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • a sodium-restricted diet
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough accompanied by excessive phlegm (mucus)
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

When using this product

  • avoid alcoholic drinks
  • do not use more than directed (see overdose warning)

Stop use and ask a doctor if

  • redness or swelling is present
  • new symptoms occur
  • nervousness, dizziness or sleeplessness occur
  • fever gets worse or lasts more than 3 days
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • 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 91-800-222-1222) 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

  • take only as recommended (see overdose warning)
  • do not exceed 5 doses(children) or 6 doses (adults per 24 hours
  • measure only with dosing cup provided
  • keep dosing cup with product
  • tbsp=tablespoon, mL= milliliter
age dose 
 adults and children 12 years and over 2 tbsp (30 mL) every 4 hours
 children 6 to 11 years1 tbsp (15 mL) every 4 hours
 children 4 to 5 yearsdo not use unless directed by a doctor
 children under 4 yearsdo not use
  • When using Day Time and Night Time products, carefully read each label to ensure correct dosing.

Other information

  • each 15 mL contains: sodium 71 mg
  • store at 20º-25ºC (68º-77ºF). Do not refrigerate.

Inactive ingredients

citric acid, FD&C yellow #6, glycerin, natural & artificial flavor, polyethylene glycol 300, propylene glycol, purified water, saccharin sodium, sodium citrate, sucrose

Principal Display Panel

Non-Drowsy

Daytime

Cold & Flu Relief

Acetaminophen 325 mg-Pain Reliever/Fever Reducer

Dextromethorphan HBr 10 mg-COugh Suppressant

Phenylephrine HCl 5 mg- Nasal Decongestant

Original Flavor

Compare to Vicks® DayQuil® active ingredients*

  • Alcohol free
  • Antihistamine free

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

Failure to follow these warnings could result in serious consequences.

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

DISTRIBUTED BY SAFEWAY INC.

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

1-888-SAFEWAY

www.safeway.com

Product Label

Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg

Safeway non drowsy daytime cold and flu relief

 

DAYTIME COLD AND FLU RELIEF  NON DROWSY
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-311
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-311-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/201412/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/201412/30/2021
Labeler - Safeway, Inc. (009137209)

Revised: 10/2019
 
Safeway, Inc.