ACETAMINOPHEN EXTRA STRENGTH, 8 SINGLE USE VIALS X 30ML EA, ADULT USE- acetaminophen 1000mg/30ml solution

Acetaminophen Extra Strength, 8 Single use vials x 30mL ea, Adult use by

Drug Labeling and Warnings

Acetaminophen Extra Strength, 8 Single use vials x 30mL ea, Adult use by is a Otc medication manufactured, distributed, or labeled by New Vision Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient Section

Active Ingredient (in each Singel Use vial, 30mL)

Acetaminophen USP, 1000mg

Purpose

Pain reliever / fever reducer

Uses

Temporarily relieves minor aches and pains due to:
■ the common cold ■ backache ■ toothache ■ headache ■ minor pain of arthritis
■ muscular aches ■ premenstrual and menstrual cramps ■ temporarily reduces fever

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4,000mg of acetaminophen in 24 hours. ■ with other drugs containing acetamintophen. ■ 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 active 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 last more than 10 days
■ fever gets worse or last 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.

Directions

■ do not take more than directed (see overdose warning).
■ do not take more than 3 single-use vials in a 24-hour period.
■ empty each Single-Use Vial of all liquid when dosing.
■ do not take for more than 10 days unless directed by a doctor.
■ use the chart below to confirm dose.

Dosing Chart

• Age (years): Dose (mL)
• Children under 12 years: Talk to a doctor
• Adults and Children 12 yeards and over: 1 Single -Use vial (30mL) every 6 hours while symptoms last. Do not take more than 3 Single - Use Vials in 24 hours

Other Information

■ each Single-Use Vial contains 30mg of sodium.
■ store at 20-25ºC (68-77ºF).
■ tamper evident: do not use if top flap of carton
is open. Do not use if any vials are open or broken.

Inactive Ingredients

citric acid, cherry flavor, edetate disodium, glycerin, maltitol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum.

Questions or Comments?

+1-800-609-04-09 Mon - Fri 9am to 6pm EST

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

OVERDOSE WARNING:

In case of accidental overdose, get medical help or contact a Poison
Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well
as for children even if you do not notice any signs or symptoms.

Package - Principal Display Panel

Unipharma

Compare to the active ingredient in Tylenol® Extra Strength*

Adult Use

ACETAMINOPHEN

Extra Strength

Pain Reliever / Fever reducer

1,000 mg per vial = 2 Gel caps of 500mg each

• Sugar Free
• Alcohol Free
• Rapid Burst Liquid

Cherry flavor

8 PRE-MESURED DOSES

1.01fl.oz. (30mL) EACH

8.12 FL.OZ. (240mL) TOTAL

Package:

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN EXTRA STRENGTH, 8 SINGLE USE VIALS X 30ML EA, ADULT USE 
acetaminophen 1000mg/30ml solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70302-069
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	3.333 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)	0.187 g  in 100 mL
WATER (UNII: 059QF0KO0R)	57.32 g  in 100 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.133 g  in 100 mL
XANTHAN GUM (UNII: TTV12P4NEE)	0.025 g  in 100 mL
SUCRALOSE (UNII: 96K6UQ3ZD4)	1.387 g  in 100 mL
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)	8.667 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	5.455 g  in 100 mL
SODIUM METABISULFITE (UNII: 4VON5FNS3C)	0.023 g  in 100 mL
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)	13 g  in 100 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.279 g  in 100 mL
MALTITOL (UNII: D65DG142WK)	14.667 g  in 100 mL
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.017 g  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	6 g  in 100 mL

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70302-069-08	8 in 1 CARTON	05/20/2020
1		30 mL in 1 VIAL; 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	05/20/2020

Labeler - Unipharma, LLC (079524332)

Establishment
Name	Address	ID/FEI	Business Operations
Unipharma, LLC		079524332	manufacture(70302-069)