FLU RELIEF THERAPY NIGHT TIME- acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid 
Family Dollar (FAMILY WELLNESS)

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 30 mL)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

Uses

Warnings

Allergy alert: Acetaminophen may cause severe skin reactions. symptoms may include:

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

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

  • to make a child sleepy
  • 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 product containing diphenhydramine, even one used on skin
  • with any other product 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 you have

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

Ask a doctor or pharmacist before use if you are taking

  • the blood thinning drug warfarin
  • sedatives or tranquilizers

When using this product

  • do not use more than directed (see overdose warning)
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • redness or swelling is present
  • nervousness, dizziness, or sleeplessness occurs
  • pain, cough or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • cough comes back or occurs with a fever, 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) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

Compare to the active ingredients in Theraflu® Nighttime Severe Cold & Cough*

For ages 12 & over 

Nighttime

Flu Relief Therapy

Severe Cold and Flu

Acetaminophen 650 mg

Pain reliever; fever reducer

Diphenhydramine HCl 25 mg

Cough suppressant; antihistamine

Phenylephrine HCl 10 mg

Nasal decongestant

Alcohol 10%

Cherry Flavor

FL OZ (mL)

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

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® Nighttime Severe Cold & Cough.

DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC

10401 MONROE RD

MATTHEWS, NC 28105 USA

VISIT FAMILYDOLLAR.COM

Product Label

Acetaminophen 650 mg, Diphenhydramine HCl 25 mg, Phenylpehrine HCl 10 mg

Family Wellness Nighttime Flu Relief Therapy

FLU RELIEF THERAPY  NIGHT TIME
acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-317
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ALCOHOL (UNII: 3K9958V90M)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTITOL (UNII: D65DG142WK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-317-08245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/31/2015
Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

Revised: 10/2021
Document Id: 5dec821b-37c4-48f5-84c3-a4c3588055a2
Set id: c5ee4265-4925-475a-be8d-92420798187d
Version: 3
Effective Time: 20211020
 
Family Dollar (FAMILY WELLNESS)