FLU RELIEF CHILDRENS- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hci suspension

Flu Relief by

Drug Labeling and Warnings

Flu Relief by is a Otc medication manufactured, distributed, or labeled by TOP CARE (Topco Associates LLC). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL)

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCI 2.5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses

• temporarily relieves the following cold/flu symptoms:
  • minor aches and pains
  • sore throat
  • cough
  • sneezing and runny nose
  • headache
  • stuffy nose 
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:

• more than 5 doses (10 mL each) in 24 hours, which is the maximum daily amount
• with other drugs contaning acetaminophen

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a 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 fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• to make a child sleepy
• with any other drug containing acetaminophen (Prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 
• in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
• if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if your child has

• liver disease
• glaucoma
• thyroid disease
• diabetes
• heart disease
• high blood pressure
• a breathing problem such as chronic bronchitis
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with asthma

Ask a doctor or pharmacist before use if the child is taking

• sedatives or tranquilizers
• the blood thinning drug warfarin

When using this product

• do not exceed recommended dose (see overdose warning )
• excitability may occur, especially in children
• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

• new symptoms occur
• redness or swelling is present
• pain, nasal congestion or cough gets worse or last more than 5 days
• fever gets worse or last more than 3 days
• nervousness, dizziness or sleeplessness occurs
• cough comes back or occurs with rash or headache that lasts, 

These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) could cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

• this product does not contain directions or complete warnings for adult use.
• mL =milliliter
• shake well before using
• do not give more than 5 doses in any 24-hour period
• measure only with dosing cup provided. Do not use any other dosing device.
• keep dosing cup with product
• if needed, repeat dose every 4 hours while symptoms last
• find the right dose on chart below. If possible, use weight to dose: otherwise, use age.

Weight (lb)	Age (yr)	Dose ( mL)
48-95	6-11	10 mL
36-47	4-5	do not use unless directed by a doctor
under 36	under 4	do not use

Other Information

• store between 20-25ºC (68-77F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C red #33, FD&C red #40, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sorbitol, sucrose xanthan gum

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

ORAL SUSPENSION

For Ages 6 to 11

Children's Pain Relief Plus Multi-Symptom

Flu Relief

FEVER REDUCER / PAIN RELIEVER (Acetaminophen)

ANTIHISTAMINE (Chlorpheniramine maleate)

COUGH SUPPRESSANT (Dextromethorphan HBr)

NASAL DECONGESTANT (Phenylephrine HCI)

Relieves:

• Fever & Sore Throat
• Sneezing & Running nose
• Cough
• Stufy nose

BUBBLE GUM FLAVOR

Compare to Children's Tylenol® Plus Flu active ingredients*

FL OZ (mL)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Plus Flu.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007 ©TOPCO

topcare@topco.com

www.topcarebrand.com

Package Label

TopCare Childrens Pain Relief Plus Multi-Symptom Flu Relief Bubble Gum Liquid

INGREDIENTS AND APPEARANCE

FLU RELIEF  CHILDRENS
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hci suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-000
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
SUCROSE (UNII: C151H8M554)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-000-04	1 in 1 BOX	07/31/2015	12/30/2021
1		118 mL in 1 BOTTLE, PLASTIC; 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	07/31/2015	12/30/2021

Labeler - TOP CARE (Topco Associates LLC) (006935977)