Label: CHILDRENS ACETAMINOPHEN ORAL SUSPENSION- acetaminophen suspension
- NDC Code(s): 60687-762-17, 60687-762-40, 60687-762-46
- Packager: American Health Packaging
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 21, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Usestemporarily:
-
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
- ASK DOCTOR
- WHEN USING
- Stop use and ask a doctor if:
- KEEP OUT OF REACH OF CHILDREN
- Overdose Warning:
-
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
- *
- 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:
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
-
Principal Display Panel – Tray – 160 mg/5 mL

Case NDC 60687-762-17/Cup NDC 60687-762-40
Children’s Acetaminophen
Oral Suspension
160 mg per 5 mLDYE 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
NDC 60687- 762-40
CHILDREN’S
ACETAMINOPHEN
ORAL SUSPENSIONPain Reliever-Fever Reducer
160 mg per 5 mL
DYE FREE/GRAPE FLAVOR
Ibuprofen Free/Alcohol Free/Aspirin FreeDelivers 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 43217F0966C50423
-
INGREDIENTS AND APPEARANCE
CHILDRENS ACETAMINOPHEN ORAL SUSPENSION
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60687-762 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 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 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:60687-762-17 10 in 1 CASE 09/06/2023 1 NDC:60687-762-46 10 in 1 TRAY 1 NDC:60687-762-40 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 09/06/2023 Labeler - American Health Packaging (929561009)

