CHILDRENS PAIN RELIEVER- acetaminophen suspension

Childrens Pain Reliever by

Drug Labeling and Warnings

Childrens Pain Reliever by is a Otc medication manufactured, distributed, or labeled by Select Brand Dist.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily reduces fever
• temporarily 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 maximum daily amount
• with other drugs containing 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

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

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 dosage (see overdose warning)

Stop use and ask a doctor if

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

These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may 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
• do not take more than directed (see Overdose warning)
• shake well before using
• mL = milliliter 
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
• if needed, repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
• do not give more than 5 days unless directed by a doctor
• find the right dose on chart below, if possable, use weight to dose; otherwise, use age.

Weight (lb)	Age (year)	Dose (mL)
under 24	under 2	ask a doctor
24-35	2-3	5 mL
36-47	4-5	7.5 ml
48-59	6-8	10 mL
60-71	9-10	12.5 mL
72-95	11	15 mL

Other information

• each 5 mL contains:sodium 2 mg 
• store between 20-25ºC (68-77ºF)
• do not refrigerate
• see bottom panel for lot number and expiration date

Inactive ingredients

acesulfame potassium, butylparaben, carboxymethylcellulose sodium, citric acid, FD&C red 40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, xanthan gum

Principal Display Panel

CHILDREN'S

PAIN RELIEVER

ACETAMINOPHEN

160 mg per 5 mL

Pain Reliever/Fever Reducer

Oral Suspension

Aspirin Free

Alcohol Free

Ibuprofen Free

For Ages 2 to 11 Years

Cherry Flavor

**Compare to the active ingredient in Children's Tylenol® Oral Suspension.

FL OZ (mL)

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

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

Distributed by:

Select Brand® Distributors

Pine Bluff, AR 71603 USA

(800)275-9015 ext 4382

Product Label

SELECT BRAND Children's Pain Reliever

INGREDIENTS AND APPEARANCE

CHILDRENS PAIN RELIEVER 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15127-508
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
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15127-508-61	1 in 1 BOX	08/05/2014
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 NOT FINAL	part343	08/05/2014

Labeler - Select Brand Dist. (012578514)