Label: ACETAMINOPHEN EXTRA STRENGTH, 8 SINGLE USE VIALS X 30ML EA, ADULT USE- acetaminophen 1000mg/30ml solution
- NDC Code(s): 70302-069-08
- Packager: New Vision Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated December 28, 2021
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- Active Ingredient 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
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.
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.
■ 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.
Age (years) Dose (mL) Children under 12 years Talk to a doctor Adults and Children 12 years and over 1 Single -Use vial (30mL) every 6 hours while symptoms last. Do not exceed 3 Single - Use Vials in 24 hours
- Other Information
- Inactive Ingredients
- Questions or Comments?
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- OVERDOSE WARNING:
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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) 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 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 06/03/2022 Labeler - New Vision Pharmaceuticals LLC (117900417) Establishment Name Address ID/FEI Business Operations New Vision Pharmaceuticals LLC 117900417 manufacture(70302-069) , label(70302-069) , pack(70302-069) , analysis(70302-069)