CHILDRENS ACETAMINOPHEN- acetaminophen suspension

Childrens Acetaminophen by

Drug Labeling and Warnings

Childrens Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Pharmaceutical Associates, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient                                                                                  (in each 5 mL teaspoonful)  

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

Temporarily:

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

Warnings

Liver warning: This product contains 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 nonprescription). 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 the recommended dose (see overdose warning)

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 the 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 children even if you do not notice any sign 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; tsp = teaspoonful
• find the right dose on chart below. If possible, use weight to dose; otherwise, use age
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours

* or as directed by a doctor
Weight (lbs)	Age (yr)	Dose (mL or tsp) *
Under 24	Under 2	Ask a doctor
24-35	2-3 years	5 mL (1 tsp)
36-47	4-5 years	7.5 mL (1 ½ tsp)
48-59	6-8 years	10 mL (2 tsp)
60-71	9-10 years	12.5 mL (2 ½ tsp)
72-95	11 years	15 mL (3 tsp)

Other information

• each 5 mL contains: sodium 2 mg
• Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
• protect from freezing
• a red, berry flavored suspension supplied in the following oral dosage form:

NDC: 0121-1781-05:  5 mL unit dose cup

NDC: 0121-1781-00:  Case contains 100 unit dose cups of 5 mL (0121-1781-05) packaged in 10 trays of 10 unit dose cups each.

Inactive ingredients

Acesulfame K, butylparaben, citric acid, high fructose corn syrup, FD&C Red No. 40, flavoring, glycerin, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Questions or comments?

Call 1-800-845-8210.

You may also report serious side effects to this phone number.

SPL UNCLASSIFIED SECTION

Pharmaceutical
Associates, Inc. Greenville, SC 29605
www.paipharma.com

R07/19

PRINCIPAL DISPLAY PANEL - 5 mL Cup

Delivers 5 mL

NDC: 0121-1781-05

C HILDREN'SA CETAMINOPHEN

O RAL S USPENSION

160 mg/5 mL

Alcohol Free / Aspirin Free

SHAKE WELL

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

A17810501

INGREDIENTS AND APPEARANCE

CHILDRENS ACETAMINOPHEN 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-1781
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
ACESULFAME (UNII: MA3UYZ6K1H)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0121-1781-00	10 in 1 CASE	09/17/2007
1		10 in 1 TRAY
1	NDC: 0121-1781-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/17/2007

Labeler - Pharmaceutical Associates, Inc. (044940096)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaceutical Associates, Inc.		097630693	manufacture(0121-1781)