Label: PAIN RELIEVER- acetaminophen solution
- NDC Code(s): 21130-945-19
- Packager: Better Living Brands, 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 September 24, 2021
If you are a consumer or patient please visit this version.
- Active ingredient (in each 30 mL)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen 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
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
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.
- do not take more than directed
- mL = milliliter; FL OZ = fluid ounce
- only use the dose cup provided
- adults and children 12 years and over
- take 30 mL every 6 hours while symptoms last
- do not take more than 90 mL in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: do not use
- Other information
- Inactive ingredients
- Questions or comments?
Principal display panel
Tylenol® Extra Strength
ACETAMINOPHEN 1,000 mg
Pain Reliever/Fever Reducer
• Alcohol Free
• Dye Free
• Contains no aspirin
8 FL OZ (237 mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED NECK
WRAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Johnson &
Johnson Corporation, distributors of Tylenol® Extra Strength.
DISTRIBUTED BY BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
QUALITY & SATISFACTION 100% GUARANTEED
OR YOUR MONEY BACK
Signature Care 44-045
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-945 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 1000 mg in 30 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-945-19 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 07/15/2021 Labeler - Better Living Brands, LLC (009137209) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 manufacture(21130-945) , pack(21130-945)