Label: EXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY- acetaminophen liquid
- NDC Code(s): 0904-5847-09
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated October 21, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients (in each 15 mL)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4000 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
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
- Do Not Use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- Stop use and ask a doctor if
- If pregnant or breast-feeding
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Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) right away.Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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Directions
- do not take more than directed (see overdose warning)
- do not take more than 4 doses in any 24 hour period
- measure only with dosing cup provided. Do not use any other dosing device
- mL=milliliter
- keep dosing cup with product
- adults and children 12 years and over
- 30 mL every 6 hours while symptoms last
- do not take more than 10 days unless directed by a doctor
- children under 12 years: do not use
- Other Information
- Inactive Ingredients
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Principal Display Panel
Major Mapap
ADULT
For ages 12 years and over
Extra Strength Actetaminophen 500 mg
Rapid Burst Cherry
Pain reliever
fever reducer
*COmpare to Extra strength Tylenol® active ingredient
Alcohol free
FL OZ (mL)
Questions or comments?
Call 1-877-753-3935Monday-Fridat 9AM-5PM EST
Distributed by: MAjor Pharmaceuticals
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSSING.
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol®
- Package label
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5847 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg in 15 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor CHERRY (Tylenol Type Cherry Rapid Blast Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-5847-09 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/02/2009 04/26/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 07/02/2009 04/26/2024 Labeler - Major Pharmaceuticals (191427277)