FLU-MED NIGHTTIME SEVERE COLD AND COUGH- acetaminophen, diphenhydramine hydrochloride, phenylephrine powder, for solution

FLU-MED by

Drug Labeling and Warnings

FLU-MED by is a Otc medication manufactured, distributed, or labeled by GRANULATION TECHNOLOGY, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each packet)

Acetaminophen 650 mg

Diphenhydramine HCI 25 mg

Phenylephrine hydrochloride 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
minor sore throat pain
sneezing
headache
nasal and sinus congestion
itchy, watery eyes due to hay fever
cough due to minor throat and bronchial irritation
temporarily reduces fever.

Warnings

Liver Warning-This product contains acetaminophen; Sever liver damage may occur if you take

more than 4000mg 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 sever skin reactions.
Symptoms may include:
skin reddening
blisters
rash
If 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 a fever, headache, rash, nausea or vomiting, consult a doctor promptly

Do not use

lf you have ever had an allergic reaction to this product or any of its ingredients

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

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 MAOI, ask a doctor or pharmacist before taking this product.

Ask doctor before use if you have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
trouble urinating due to enlarged prostate gland
cough that occurs with too much phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers
taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage
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

new symptoms occur
nervousness, dizziness, or sleeplessness occurs
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
pain, cough or nasal congestion gets worse or lasts more than 7 days
cough comes back or occurs with fever, rash or headache that lasts.
These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

Overdose warning. In case of overdose, get medical help or contact a Poison Control Center right away (1 800 222-1222).Prompt 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 more than directed (see Overdose Warning)
take every 4 hours, while symptoms persist. Do not take more than 5
packets in 24 hours unless directed by a doctor.
children under 4 years of age: do not use
children 4 to 12 years of age: do not use unless directed by a doctor
Adults and children over 12 years of age: One packet
dissolve contents of one packet into 8 oz hot water, sip while hot.
Consume entire drink within 10-15 minutes using a microwave, add contents of one packet to 8 oz cool water, stir briskly before and after heating. Do not overheat.

Other information

This product does not contain Aspartame
store at a controlled room temperature 20-25C (68-77F). Protect from excessive heat & moisture.

Inactive ingredients

Sucrose, Sucralose,Maltodextrin, FD&C Yellow #10, Citric Acid, Colloidal Silicon Dioxide, Flavors, Tribasic Calcium Phosphate.

Outer Package

Inner Package

INGREDIENTS AND APPEARANCE

FLU-MED   NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, diphenhydramine hydrochloride, phenylephrine powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63561-0128
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Product Characteristics
Color		Score
Shape		Size
Flavor	HONEY, LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63561-0128-6	6 in 1 CARTON	03/01/2018
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2018

Labeler - GRANULATION TECHNOLOGY, INC. (847132193)