Flu Relief Therapy by AmerisourceBergen (Good Neighbor Pharmacy) 46122 Drug Facts

Flu Relief Therapy by

Drug Labeling and Warnings

Flu Relief Therapy by is a Otc medication manufactured, distributed, or labeled by AmerisourceBergen (Good Neighbor Pharmacy) 46122. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FLU RELIEF THERAPY NIGHTTIME- acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid 
AmerisourceBergen (Good Neighbor Pharmacy) 46122

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

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

Uses

  • temporarily relieves
    • minor aches and pains
    • sneezing
    • headache
    • minor sore throat pain
    • itchy, watery eyes
    • nasal and sinus congestion
    • runny nose
    • cough due to minor throat and bronchial irritation
    • itchy nose or throat
  • temporarily reduces fever

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, which is the maximum daily amount
  • 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

  • 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

  • do not use in infants
  • do not exceed recommended dose (see overdose warning)
  • use dosage cup provided
  • tbsp=tablespoon, mL= milliliter

Do not take more than 6 doses (12 tablespoons) in 24 hours.

 age dosage
 adults and children 12 years and over 2 tablespoons (30 mL) every 4 hours
 children 4 to 11 years do not use unless directed by a doctor
 children under 4 years do not use

Other information

  • each 15 mL contains: potassium 5 mg, sodium 7 mg
  • store at room temperature

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 Flu Relief Therapy

Severe Cold

Acetaminophen

Pain reliever; fever reducer

Diphenhydramine HCl

Cough suppressant; antihistamine

Phenylephrine HCl

Nasal decongestant

Relief of:

Nasal congestion; runny nose; cough; fever; body ache; sore throat; headache

Alcohol Content: 10%

Cherry Flavor

For ages 12 & over

FL OZ (mL)

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

Failure to follow the drug facts warnings could result in serious consequences.

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

Distributed by AmerisourceBergen

1300 Morris Drive Chesterbrook, PA 18087

Product Label

Acetaminophen 325 mg, Diphenhdyramine HCl 12.5 mg, Phenylephrine HCl 5 mg

Good Neighbor Pharmacy Nighttime Flu Relief Therapy

FLU RELIEF THERAPY  NIGHTTIME
acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 46122-016
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 15 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 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: 46122-016-33245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/201312/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/30/201312/31/2019
Labeler - AmerisourceBergen (Good Neighbor Pharmacy) 46122 (007914906)

Revised: 12/2018
 
AmerisourceBergen (Good Neighbor Pharmacy) 46122