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

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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FLU-MED NIGHTTIME SEVERE COLD & COUGH



Honey Lemon Infused with Camomile & White Tea Flavors

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

FluMed-NighttimeOuter

Inner Package

FluMed-NighttimeInner

FLU-MED  NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, diphenhydramine hydrochloride, phenylephrine powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63561-0128
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorHONEY, LEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63561-0128-66 in 1 CARTON03/01/2018
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/201808/31/2020
Labeler - GRANULATION TECHNOLOGY, INC. (847132193)

Revised: 5/2021
 
GRANULATION TECHNOLOGY, INC.