OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mL

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mL
Generic name: ACETAMINOPHEN 160 MG / 5 ML
Manufacturer: MEDWISE LIFESCIENCES INC.
Product type: HUMAN OTC DRUG
SPL set ID: 40507559-aee4-a603-e063-6394a90afc4f
SPL ID: 40507559-aee5-a603-e063-6394a90afc4f
Version: 1
Effective date: 2025-10-04
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:34:32

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M013	openfda.application_number
brand name		OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mL	openfda.brand_name
generic name		ACETAMINOPHEN 160 MG / 5 ML	openfda.generic_name
manufacturer name		MEDWISE LIFESCIENCES INC.	openfda.manufacturer_name
ndc	package	87078-121-52	openfda.package_ndc
ndc	product	87078-121	openfda.product_ndc
ndc11	package	87078012152	derived:openfda.package_ndc
rxcui		307668	openfda.rxcui
spl id		40507559-aee5-a603-e063-6394a90afc4f	id
spl set id		40507559-aee4-a603-e063-6394a90afc4f	set_id
unii		362O9ITL9D	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.