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NDC 00121-0973-08 Childrens Pain and Fever 160 mg/5mL Details

Childrens Pain and Fever 160 mg/5mL

Childrens Pain and Fever is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by PAI Holdings, LLC. The primary component is ACETAMINOPHEN.

Product Information

NDC	00121-0973
Product ID	0121-0973_325c94eb-443a-41bd-9368-321720d788b3
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Childrens Pain and Fever
Proprietary Name Suffix	n/a
Non-Proprietary Name	Childrens Pain and Fever
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	160
Active Ingredient Units	mg/5mL
Substance Name	ACETAMINOPHEN
Labeler Name	PAI Holdings, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00121-0973-08 (00121097308)

Pricing Information	N/A
NDC Package Code	0121-0973-08
Billing NDC	00121097308
Package	1 BOTTLE in 1 CARTON (0121-0973-08) / 237 mL in 1 BOTTLE
Marketing Start Date	2022-11-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 10467f34-d9b1-41ff-9493-af6b649eb322 Details

Active ingredient

(in each 5 mL)

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 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 has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if 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.

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 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 give 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.
remove the child protective cap and squeeze your child’s dose into the dosing cup
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours

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

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

Other information

each 5 mL contains: sodium 2 mg
store at 20° to 25°C (68° to 77°F)
do not use if printed neckband is broken or missing

Inactive ingredients:

acesulfame K, butylparaben, citric acid, D&C Red No. 33, FD&C Blue No. 1, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Questions or comments?

1-800-845-8210

**This product is not manufactured or distributed by

Johnson & Johnson Consumer Inc., distributor of

Children’s Tylenol® Oral Suspension.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2022 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-38612

Principal Display Panel

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

Suspension Liquid

NDC 0121-0973-08

Children’s Pain & Fever

ACETAMINOPHEN

160 mg / 5 mL

Pain reliever; Fever reducer

Ages 2 to 11 years

Free of:

• Added Alcohol

• Aspirin

• Ibuprofen

Grape Flavor

Use ONLY Enclosed Dosing Cup

Actual Bottle Size on Side Panel

8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS PAIN AND FEVER

childrens pain and fever suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0121-0973
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
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)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0121-0973-08	1 in 1 CARTON	11/21/2022
1		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	11/21/2022

Labeler - PAI Holdings, LLC (044940096)

Revised: 11/2022

Document Id: 325c94eb-443a-41bd-9368-321720d788b3

Set id: 10467f34-d9b1-41ff-9493-af6b649eb322

Version: 4

Effective Time: 20221123