FLU RELIEF THERAPY NIGHT TIME- theraflu nighttime liquid

Flu Relief Therapy Night Time by

Drug Labeling and Warnings

Flu Relief Therapy Night Time by is a Otc medication manufactured, distributed, or labeled by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Nite Time Severe cold and cough cherry flavor

pain reliever, fever reducer acetaminophen

cough suppressant antihistamine, diphenhydramine hcl

nasal decongestant phenylephrine hcl

compare to active ingredient in theraflu

alcohol 10 percent

100 percent quality quaranteed 888-309-9030

distributed by dolgencorp, inc. llc

100 mission ridge, goodlettsville tn 37072

made in usa

INGREDIENTS AND APPEARANCE

FLU RELIEF THERAPY NIGHT TIME 
theraflu nighttime liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-154
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (Theraflu Type Cherry Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-154-08	245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/26/2013	12/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/26/2013	12/30/2021

Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)