CHILDRENS ACETAMINOPHEN ORAL SUSPENSION- acetaminophen suspension 
American Health Packaging

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Childrens Acetaminophen Oral Suspension
Drug Facts

Active ingredient

(in each 5 mL)
Acetaminophen160 mg

Purpose

Pain reliever/fever reducer

Usestemporarily:

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if your child takes

Allergy alert:acetaminophen may cause severe skin reactions.
Symptoms may include:

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

Ask a doctor before use if your child hasliver disease.

Ask a doctor or pharmacist before use if your childis 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:

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 children even if you do not notice any sign or symptoms.

Directions

*
or as directed by a doctor

Weight (lb)

Age (yr)

Dose (mL)*

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL (1 unit dose cup)

36-47

4-5 years

7.5 mL (1.5 unit dose cups)

48-59

6-8 years

10 mL (2 unit dose cups)

60-71

9-10 years

12.5 mL (2.5 unit dose cups)

72-95

11 years

15 mL (3 unit dose cups)

Other information

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.

DO NOT USE IF SEAL IS BROKEN.

Distributed by:
American Health Packaging
Columbus, OH 43217

T0966C050423
R04/23

Principal Display Panel – Tray – 160 mg/5 mL

160 mg/5 mL Children’s Acetaminophen Oral Suspension Tray Label

Case NDC 60687-762-17/Cup NDC 60687-762-40

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

USUAL DOSAGE:See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)

For Institutional Use Only.

T0966C050423            R04/23

Principal Display Panel – Cup – 160 mg/5 mL

160 mg/5 mL Children’s Acetaminophen Oral Suspension Cup

NDC 60687- 762-40

CHILDREN’S
ACETAMINOPHEN
ORAL SUSPENSION

Pain Reliever-Fever Reducer

160 mg per 5 mL

DYE FREE/GRAPE FLAVOR
Ibuprofen Free/Alcohol Free/Aspirin Free

Delivers 5 mL

SHAKE WELL BEFORE USING

See package Drug Facts inert for full
prescribing information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

F0966C50423

CHILDRENS ACETAMINOPHEN ORAL SUSPENSION 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-762
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Colorwhite (to off-white appearance) Score    
ShapeSize
FlavorGRAPE (grape flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60687-762-1710 in 1 CASE08/01/2023
1NDC:60687-762-4610 in 1 TRAY
1NDC:60687-762-405 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/01/2023
Labeler - American Health Packaging (929561009)

Revised: 8/2023
Document Id: 0191bc62-aa7f-874a-e063-6294a90a95b9
Set id: 8231dd91-e9e6-4350-a485-fa95d65a6d25
Version: 1
Effective Time: 20230801
 
American Health Packaging