DYE FREE CHILDRENS ACETAMINOPHEN- acetaminophen suspension

Childrens Acetaminophen Oral Suspension by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

(in each 5 mL)
Acetaminophen 160 mg

Purpose

Acetaminophen
160 mg.............................Pain reliever/fever reducer

Uses temporarily:

• reduces fever
• 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 DOCTOR

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

When using this product do not exceed 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 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
• find 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

Attention: For Single-Dose Cups, the entire dose should be taken.

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

*or as directed by a doctor

Other information

• each 5 mL contains: sodium: 2 mg
• Store at 20° to 25°C (68° to 77°F)
• grape flavored suspension supplied in the following oral dosage form:

   NDC: 0121-0966-05: 5 mL unit dose cup, in a tray of ten cups.

   NDC: 0121-0966-94: Case contains 30 unit dose cups of 5 mL (0121-0966-05) packaged in 3 trays of 10 unit dose cups each.
   NDC: 0121-0966-00: Case contains 100 unit dose cups of 5 mL (0121-0966-05) packaged in 10 trays of 10 unit dose cups each.

INACTIVE INGREDIENT

Inactive ingredients: acesulfame K, butylparaben, citric acid, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Questions or Comments?

Call 1-800-845-8210.

MANUFACTURED BY:

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

R01/22

Principal Display Panel

Delivers 5 mL

NDC: 0121-0966-05

DYE FREE/GRAPE FLAVOR

Children's Acetaminophen Oral Suspension

160 mg per 5 mL

DYE FREE/GRAPE FLAVOR

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

SEE INSERT

INGREDIENTS AND APPEARANCE

DYE FREE CHILDRENS ACETAMINOPHEN 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-0966
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
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	white (to off-white appearance)	Score
Shape		Size
Flavor	GRAPE (grape flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0121-0966-94	3 in 1 CASE	03/09/2022
1		10 in 1 TRAY
1	NDC: 0121-0966-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 0121-0966-00	10 in 1 CASE	03/09/2022
2		10 in 1 TRAY
2	NDC: 0121-0966-05	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
OTC Monograph Drug	M013	03/09/2022

Labeler - PAI Holdings, LLC dba PAI Pharma (044940096)

Establishment
Name	Address	ID/FEI	Business Operations
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma		097630693	label(0121-0966) , manufacture(0121-0966)