FLU RELIEF THERAPY DAY TIME- theraflu daytime liquid

Flu Relief Therapy Day Time by

Drug Labeling and Warnings

Flu Relief Therapy Day Time by is a Otc medication manufactured, distributed, or labeled by P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Acetaminophen  325 mg
Dextromethorphan HBr  10 mg
Phenylephrine HCI  5 mg

Purposes

Acetaminophen............................Pain reliever/fever reducer
Dextromethorphan HBr...............Cough suppressant
Phenylephrine HCI......................Nasal decongestant

Uses

temporarily relieves
minor aches and pains
headache minor sore throat pain
nasal congestion
cough due to minor throat and
bronchial irritation
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

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 acetaminophen
containing products. This may
lead to an overdose,which may
cause liver damage.
(see overdose warning)

Ask a doctor before use if you have

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

When using this product

do not use more than directed
(see overdose warning)

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
Drug Facts (continued)
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: 8 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

cherry

flu relief therapy

daytime cold and cough

acetaminophen

fever and sore throat

dextromethorphan HBr

cough

phenylephrine HCL

stuffy nose

for ages 12 and over

alcohol 10 percent

manufactured by aaron industries

PO Box 801

Lynwood, CA 90262

compare to the actived ingredients in theraflu

8.3 fl oz (245mL)

INGREDIENTS AND APPEARANCE

FLU RELIEF THERAPY DAY TIME 
theraflu daytime liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49580-0155
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
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 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 RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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: 49580-0155-8	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/11/2013	12/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/11/2013	12/30/2021

Labeler - P & L Development, LLC (101896231)