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

Manufacturer
New Vision Pharmaceuticals LLC
Effective date
2021-12-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:20:31

Label at a glance#

ProductAcetaminophen Extra Strength, 8 Single use vials x 30mL ea, Adult use
Active ingredientACETAMINOPHEN
Label structure11 sections

Indications and 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

Dosage and administration

■ 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 years and over 1 Single -Use vial (30...

Storage and handling

■ 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.

Label contents#

Full prescribing information#

Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

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

Acetaminophen USP, 1000mg

Purpose

OTC - PURPOSE SECTION

Pain reliever / fever reducer

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

■ 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

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

STORAGE AND HANDLING SECTION

■ 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

OVERDOSE WARNING:

OVERDOSAGE SECTION

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 LABEL.PRINCIPAL DISPLAY PANEL

PackagePackage

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70302-06970302-069-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d441623e-643d-dd1f-e053-2a95a90aa515a4738c36-c7cf-2f6f-e053-2995a90afcd02021-12-28WarningsExact identifier
spl id: d441623e-643d-dd1f-e053-2a95a90aa515
spl set id: a4738c36-c7cf-2f6f-e053-2995a90afcd0

Reported adverse events (FAERS/openFDA)#

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