CHILDRENS PAIN AND FEVER- acetaminophen liquid

Childrens Pain and Fever by

Drug Labeling and Warnings

Childrens Pain and Fever by is a Otc medication manufactured, distributed, or labeled by Discount Drug Mart, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive ingredient(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily

• reduces fever
• relieves minor aches and pains due to:
• the common cold
• flu
• headache
• sore throat
• toothache  
  

Warnings

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

• more than 5 doses in 24 hours, which is the maxium daily amount
• with other drugs containing acteaminophen

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

• skin reddening
• blisters
• rash

If a skin reaction occurs, stopuse and seek medical help right away.

Sore throat warning: If a sore throat is severe, persiss for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Do not use

• 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 your child is allergic to acetaminophen or to any of the inactive ingredients in this product

Ask a doctor if your child has

liver disease

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

When using this product do not exceed recommended dose.

(see overdose warnings)

Stop use and ask a doctor if

• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition.

Keep out of reach of children.

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) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• this product does not contain directions or complete warnings for adult use.
• shake well before using
• mL = millititer; tsp = teaspoonful
• find right dose on chart below. If possible, use weight to dose, otherwise, use age.
• if needed, repeat dose every 4 hours while symptoms last
• do not give for more than 5 days unless directed by a doctor

Weight (lb)        Age (yr)            Dose (mL or Tsp)*
under 24           under 2 years    ask a doctor

24-35               2-3 years           5 mL (1 tsp)

36-47               4-5 years           7.5 mL (1 1/2 tsp)

48-59               6-8 years           10 mL (2 tsp)

60-71               9-10 years          12.5 mL (2 1/2 tsp)

72-95               11 years              15 mL

* or as directed by a doctor

Attention: use only enclosed dosing cup specfically designed for use with this product. Do not use any other dosing dvice

Other information

• eash 5mL (1 tsp) contains sodium 3mg
• store between 20-25

Inactive ingrediants

anhydrous citric acid, butylparaben, D&C Red # 33, FD&C (red), flavor, glycerin, flavor, high frucotose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum   

Questions

Call weekays from 9:30 AM to 4:30 PM

Children's Pain & Fever product label

DISCOUNT
drug mart
FOOD FAIR

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S TYLENOL® ORAL SUSPENSION

Fever Reducer / Pain Reliever

Children's Pain & Fever

Acetaminophen Oral Suspension

• Alcohol-Free
• Ibuprofen Free
• Aspirin Free

For Ages 2 to 11

GRAPE FLAVOR

4 FL OZ (118 mL)
160 mg per 5 mmL

* This product is not manufactures or distributed by McNeil Consumer Healthcare, distribbutor of Children's Tylenol® Oral Suspension.

BX-053

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN THE UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STOORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS, AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

INGREDIENTS AND APPEARANCE

CHILDRENS PAIN AND FEVER 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53943-526
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

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	grape	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53943-526-24	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/04/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	08/04/2016

Labeler - Discount Drug Mart (047741335)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(53943-526)