FLU RELIEF THERAPY NIGHTTIME- acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid

Flu Relief Therapy by

Drug Labeling and Warnings

Flu Relief Therapy by is a Otc medication manufactured, distributed, or labeled by QUALITY CHOICE (Chain Drug Marketing Association). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Warnings

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

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day 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

• 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
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• 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)
• alcohol, sedative, and tranquilizers may increase drowsiness 
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• marked drowsiness may occur 
• excitability may occur, especially in children

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• 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
• redness or swelling is present 
• 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) 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 6 doses in any 24-hour period
• measure only with dosing cup provided. Do not use any other dosing device
• mL=milliliter
• keep dosing cup with product
• adults and children 12 years and over
  • 30 mL every 4 hours
• children under 12 years of age; do not use 

Other information

• each 30 mL contains: potassium 10 mg
• each 30 mL contains: sodium 14 mg
• store at 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

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

Principal Display Panel

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

Nighttime

Flu Relief Therapy

Cold & Cough

Acetaminophen

Pain reliever / fever reducer

Diphenhydramine HCl

Cough suppressant

Phenylephrine HCl

Nasal decongestant

For Ages 12 & Over

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., distributor of Theraflu® Nighttime Severe Cold & Cough.

Distributed by C.D.M.A., Inc.,©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Question: 248-449-9300

Product Label

Quality Choice Nighttime Flu Relief Therapy

INGREDIENTS AND APPEARANCE

FLU RELIEF THERAPY  NIGHTTIME
acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-958
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-958-08	245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/31/2015	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/31/2015	12/31/2020

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)