ONESSIP ACETAMINOPHEN ORAL SUSPENSION BUBBLE GUM 5 ML- acetaminophen 160 mg / 5 ml suspension

OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mL by

Drug Labeling and Warnings

OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mL by is a Otc medication manufactured, distributed, or labeled by MEDWISE LIFESCIENCES INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

• Temporarily reduces fever
• Temporarily relieves minor aches and pains 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

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 is allergic to acetaminophen or any of the inactive ingredients in this product

ASK DOCTOR

Ask a doctor before use if your child has liver disease

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

WHEN USING

When using this product do not exceed recommended dose (see overdose warning)

STOP USE

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

Keep out of reach of children.

OVERDOSAGE

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

DOSAGE & ADMINISTRATION

Directions

• this product does not contain directions or complete warnings for adult use.
• do not give more than directed (see overdose warning)
• Follow the instruction given on this carton for your easy use.

• Age (Years):

  Dose (mL)*

• Under 2 Years:

  Ask a doctor

• 2 to under 6:

  1 Sachet (5 mL)

• 6 to 11 years:

  2 Sachets (10 mL)

*dose may be repeated every 4 hours while symptoms persist, upto five times a day or as directed by a doctor.

mL = milliliter

STORAGE AND HANDLING

Other information

• store between 20-25°C (68-77°F)
• do not use if carton or sachet is torn, broken or punctured.

INACTIVE INGREDIENT

Inactive Ingredient

anhydrous citric acid, FD&C Red No. 40, flavors, glycerin, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum

QUESTIONS

Question or Comments?

call 1-516-675-8915

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ONESSIP ACETAMINOPHEN ORAL SUSPENSION BUBBLE GUM 5 ML 
acetaminophen 160 mg / 5 ml suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87078-121
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
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87078-121-52	12 in 1 CARTON	10/01/2025
1		5 mL in 1 POUCH; 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	10/01/2025

Labeler - MEDWISE LIFESCIENCES INC. (140161518)