DAY TIME 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 15 mL)

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:

  • adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount 
  • child takes more than 4 doses (15 mL each) in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks everyday 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

  • 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
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • a sodium-restricted diet
  • 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

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion,or cough gets worse, or lasts more than 5 days(children) or 7 days (adult)
  • fever gets worse, or last more than 3 days
  • redness or swelling is present
  • new symptom 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 (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 4 doses in any 24-hours period
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • mL = milliliter
adults and children 12 years and over 30 mL every 4 hours
children 6 to under 12 years 15 mL every 4 hours
children 4 to under 6 years ask a doctor
children under 4 years  do not use

  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information

  • each 15 mL contains: sodium 12 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate

Inactive ingredients

citric acid, FD&C yellow 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate,sorbitol, sucralose, xanthan gum

Questions or comments?

Call 1-888-723-3929 Monday-Friday 7AM-6PM PST 

Principal Display Panel

Compare to Vicks® DayQuil® active ingredients*

Non-Drowsy

Day Time

Cold & Flu Relief

Acetaminophen 325 mg - Pain reliever/fever reducer

Dextromethorphan HBr 10mg - Cough suppressant

Phenylephrine HCl 5 mg - Nasal Decongestant

ORIGINAL FLAVOR

  • Relieves aches, fever, sore throat, cough & nasal congestion
  • Alcohol free
  • Antihistamine free

For Ages 6 & Over

FL OZ (mL)

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and DayQuil® are registered trademarks of The Proctor & Gamble Company.

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

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA

94566-0009

www.betterlivingbrandsLLC.com

Product Label

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

SIGNATURE CARE Non-Drowsy DayTime Cold & Fly Relief

DAY TIME COLD AND FLU RELIEF  NON DROWSY
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-866
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)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-866-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2015
2NDC:21130-866-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/31/2015
Labeler - Safeway, Inc. (009137209)

Revised: 10/2019
 
Safeway, Inc.