FLU RELIEF THERAPY NIGHT TIME- acetaminophen, diphenhydramine hydrochloride and phenylephrine hydrochloride liquid 
CVS

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

Acetaminophen  325 mg
Diphenhydramine HCl  12.5 mg
Phenylephrine HCI  5 mg

Purposes

Acetaminophen..........................Pain reliever/fever reducer
Diphenhydramine HCl...............Antihistamine/Cough suppressant
Phenylephrine HCI.....................Nasal decongestant

Uses

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

Warnings

Alcohol warning: If you consume
3 or more alcoholic drinks every day,
ask your doctor whether you should
take acetaminophen or other pain
relievers/fever reducers.
Acetaminophen may cause liver
damage.
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 on a sodium-restricted
diet • 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 two
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
acetaminophen containing
products. This may lead to an
overdose,which may cause liver
damage. (see overdose warning)

Ask a doctor

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

Ask a doctor or pharmacist before use if you are

taking 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
• you get nervous, dizzy or sleepless
• pain, cough or nasal congestion
gets worse or lasts more than
7 days • fever gets worse or lasts
more than 3 days • new symptoms
occur • sore throat is severe,
persists for more than 2 days, is
accompanied or followed by fever,
headache, rash, nausea, or
vomiting • 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 this and all drugs out of the reach of children.

Overdose Warning: Taking more
than the recommended dose
(overdose) could cause serious
health problems, including liver
damage. In case of accidental
overdose, seek professional
assistance or contact a Poison
Control Center 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 exceed recommended
dosage (see overdose warning)
• do not use in infants

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

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

Other Information

• sodium content
per tablespoon:
7 mg
• potassium content
per tablespoon:
5 mg
• store at controlled room temperature

Inactive Ingredients

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

Principal Display Panel

image of label

FLU RELIEF THERAPY NIGHT TIME 
theraflu nighttime liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-154
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg  in 15 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
Acesulfame Potassium 
Alcohol 
CITRIC ACID MONOHYDRATE 
Edetate Disodium 
Glycerin 
Maltitol 
Propylene Glycol 
Water 
Sodium Benzoate 
Sodium Citrate 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
Product Characteristics
Colorred (red) Score    
ShapeSize
FlavorCHERRY (Theraflu Type Cherry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-154-08245 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2009
Labeler - CVS (062312574)
Registrant - Aaron Industries, Inc. (113044205)
Establishment
NameAddressID/FEIBusiness Operations
Aaron Industries, Inc.113044205manufacture(59779-154), analysis(59779-154)

Revised: 3/2013
Document Id: 68829cc4-c08f-4c24-a37b-7735bca8ef58
Set id: 3b98a5e3-56fa-40a7-999a-5b43806f9405
Version: 1
Effective Time: 20130320
 
CVS