Acetaminophen by VistaPharm, Inc. ACETAMINOPHEN solution

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by VistaPharm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

■ temporarily relieves minor aches and pains due to:

■ headache

■ muscle aches

■ backache

■ minor pain of arthritis

■ the common cold

■ toothache

■ premenstrual and menstrual cramps

■ temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

■ more than 4000 mg in 24 hours

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product

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.

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

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

■ pain gets worse or lasts more than 10 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.

If pregnant or breast-feeding, ask a health professional before use.

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

■ do not take more than directed (see overdose warning)

■ do not take more than 4 doses in any 24-hour period

■ dose as follows or as directed by doctor

■ take only with dosing cup provided

■ adults and children 12 years of age and older: 20 mL (640 mg) in dosing cup every 6 hours

■ children under 12 years of age: ask a doctor

Other information

■ each 5 mL contains: sodium 8 mg

■ store at 20 -25°C (68 -77°F)

■ do not use if foil on cup is missing or torn

Inactive ingredients

anhydrous citric acid, FD&C blue no. 1, FD& C red no. 40, flavor, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, sodium saccharin

Questions or comments?

Call 1-888-655-1505

How Supplied

NDC: 66689-054-01: 5 mL unit-dose cup

NDC: 66689-054-99: Case contains 100 unit-dose cups of 5 mL (NDC: 66689-054-01), packaged in 10 trays of 10 unit-dose cups each.

Distributed by:

VistaPharm Inc.

Largo, FL 33771, USA

VP2510

10/2019

Principal Display Panel - 5 mL Lidding Label

ACETAMINOPHEN Oral Solution, USP     

160 mg per 5 mL

Alcohol-Free

Delivers 160 mg [5 mL]

Store at 20°- 25°C (68°-77°F); [See USP CRT conditions].

Distributed by:

VistaPharm, Inc.
Largo, FL 33771, USA

NDC: 66689-054-01

VP2154R2

02/18

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66689-054
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66689-054-99	10 in 1 CASE	11/22/2019
1		10 in 1 TRAY
1	NDC: 66689-054-01	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 NOT FINAL	part343	11/22/2019

Labeler - VistaPharm, Inc. (116743084)