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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Acetaminophen Extra Strentgh Adult use

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 (120mL) single-use vials (4,000mg) 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 yearsTalk to a doctor
Adults and Children 12 years and over1 Single -Use vial (30mL) every 6 hours while symptoms last. Do not exceed 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.

Principal Display Panel

Package

ACETAMINOPHEN EXTRA STRENGTH, 8 SINGLE USE VIALS X 30ML EA, ADULT USE 
acetaminophen 1000mg/30ml solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70302-069
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN3.333 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
WATER (UNII: 059QF0KO0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MALTITOL (UNII: D65DG142WK)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70302-069-088 in 1 CARTON05/20/2020
130 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/20/202006/03/2022
Labeler - New Vision Pharmaceuticals LLC (117900417)
Establishment
NameAddressID/FEIBusiness Operations
New Vision Pharmaceuticals LLC117900417manufacture(70302-069) , label(70302-069) , pack(70302-069) , analysis(70302-069)

Revised: 12/2021
 
New Vision Pharmaceuticals LLC