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NDC 00121-0939-00 Childrens Acetaminophen 160 mg/5mL Details

Childrens Acetaminophen 160 mg/5mL

Childrens Acetaminophen is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is ACETAMINOPHEN.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 00121-0939-00
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	00121-0939
Product ID	0121-0939_e5d6567e-a8f6-5bb7-e053-2a95a90a0f87
Associated GPIs	64200010001840
GCN Sequence Number	065752
GCN Sequence Number Description	acetaminophen ORAL SUSP 160 MG/5ML ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	27794
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Childrens Acetaminophen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	160
Active Ingredient Units	mg/5mL
Substance Name	ACETAMINOPHEN
Labeler Name	Pharmaceutical Associates, Inc.
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 00121-0939-00 (00121093900)

Pricing Information	N/A
NDC Package Code	0121-0939-00
Billing NDC	00121093900
Package	10 TRAY in 1 CASE (0121-0939-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0939-05)
Marketing Start Date	2021-02-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b9bccbf8-f9c4-abe7-e053-2995a90a943e Details

Uses

temporarily:

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

Purpose

Pain reliever/fever reducer

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

SPL UNCLASSIFIED SECTION

Drug Facts

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if

• 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 you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if the user has liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

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.

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

• 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

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
Over 96	adults and children 12 years and over	20 mL

Other information

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

NDC 0121-0939-05: 5 mL unit dose cup, in a tray of ten cups.

NDC 0121-1878-10: 10 mL unit dose cup, in a tray of ten cups.

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.

SPL UNCLASSIFIED SECTION

Call 1-800-845-8210.

SPL UNCLASSIFIED SECTION

Manfactured By

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

Delivers 5 mL

NDC 0121-0939-05

CHILDREN'S ACTAMINOPHEN ORAL SUSPENSION

160 mg per 5 mL

DYE FREE

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

SEE INSERT

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

PRINCIPAL DISPLAY PANEL - 10 mL Cup Label

Delivers 10 mL

NDC 0121-1878-10

CHILDREN'S ACTAMINOPHEN ORAL SUSPENSION

320 mg per 10 mL

DYE FREE

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

SEE INSERT

PRINCIPAL DISPLAY PANEL - 10 mL Cup Label

INGREDIENTS AND APPEARANCE

CHILDRENS ACETAMINOPHEN

acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0121-0939
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
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
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)

Product Characteristics
Color	white (clear, dye-free)	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0121-0939-00	10 in 1 CASE	02/05/2021
1		10 in 1 TRAY
1	NDC:0121-0939-05	5 mL in 1 CUP, UNIT-DOSE; 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	01/29/2021

CHILDRENS ACETAMINOPHEN

acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0121-1878
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	320 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
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)

Product Characteristics
Color	white (clear, dye-free)	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0121-1878-00	10 in 1 CASE	02/05/2021
1		10 in 1 TRAY
1	NDC:0121-1878-10	10 mL in 1 CUP, UNIT-DOSE; 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	01/29/2021

Labeler - Pharmaceutical Associates, Inc. (044940096)

Registrant - Pharmaceutical Associates, Inc. (097630693)

Name	Address	ID/FEI	Business Operations
Establishment
Pharmaceutical Associates, Inc.		097630693	manufacture(0121-0939, 0121-1878) , label(0121-0939, 0121-1878)

Revised: 8/2022

Document Id: e5d6567e-a8f6-5bb7-e053-2a95a90a0f87

Set id: b9bccbf8-f9c4-abe7-e053-2995a90a943e

Version: 5

Effective Time: 20220809

Search by Drug Name or NDC

NDC 00121-0939-00 Childrens Acetaminophen 160 mg/5mL Details

Childrens Acetaminophen 160 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00121-0939-00 (00121093900)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b9bccbf8-f9c4-abe7-e053-2995a90a943e Details

Uses

Purpose

Active ingredient (in each 5 mL)

SPL UNCLASSIFIED SECTION

Warnings

Liver warning

Allergy alert

Sore throat warning

Do not use

Stop use and ask a doctor if

Overdose warning

Directions

Other information

Inactive ingredients

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

PRINCIPAL DISPLAY PANEL - 10 mL Cup Label

INGREDIENTS AND APPEARANCE

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