DayRelief by Western Family Foods, Inc. Drug Facts

DayRelief by

Drug Labeling and Warnings

DayRelief by is a Otc medication manufactured, distributed, or labeled by Western Family Foods, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DAYRELIEF MULTI SYMPTOM- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid 
Western Family Foods, 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, 1 tablespoon)

Acetaminophen 325 mg

Dextromethoprhan HBr 10 mg

Phenlyephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

  • temporarily relieves common cold and flu symptoms
    • minor aches and pain
    • 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:

  • adult takes more than 4,000 mg of acetaminophen in 24 hours

  • child takes more than 5 doses in 24 hours

  • with other drugs containing acetaminophen

  • 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

  • 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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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 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 exceed recommended dosage.

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occurs
  • pain, nasal congestion, or cough gets worse, or last more than 5 days (Children) or 7 days (adult)
  • fever gets worse or lasts 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?

Call 1-503-639-6300 Monday-Friday 8AM-4PM PST

Principal Display Panel

DayRelief

NON-DROWSY MULTI-SYMPTOM COLD/FLU

PAIN RELIEVER, FEVER REDUCER, COUGH SUPPRESSANT, NASAL DECONGESTANT

 ACETAMINOPHEN ____________aches, fever

DEXTROMETHORPHAN HBr__________cough

PHENYLEPHRINE HCI__________nasal congestion

FOR AGES 6 & OVER

ALCOHOL FREE

ANTIHISTAMINE FREE

FL OZ (mL)

COMPARE TO VICKS® DAYQUIL® active ingredients*

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

*This product is not manufactured or distributed by the Procter & Gamble Company,Vicks® and Dayquil® are registered trademarks of the Procter & Gamble Company.

Proudly Distributed by Western Family, Inc.

P.O. Box 4057, Portland, OR 97208 USA

www.westernfamily.com

Package Label

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCI 5 mg

Western Family Day Relief Non-Drowsy Multi-Symptom Cold-Flu

DAYRELIEF  MULTI SYMPTOM
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55312-066
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
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: 55312-066-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201512/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/201512/31/2019
Labeler - Western Family Foods, Inc. (192166072)

Revised: 12/2018
 
Western Family Foods, Inc.