Label: PAIN RELIEVER FEVER REDUCER EXTRA STRENGTH- acetaminophen liquid
- NDC Code(s): 69842-878-08
- Packager: CVS Pharmacy
- 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.
Drug Label Information
Updated October 30, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each 15 mL)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 90 mL (6 tbsp) (3,000 mg) in 24 hours. 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 ever 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.
Stop use and ask a doctor if
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help 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 then 4 doses in any 24 hours 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
- Questions or comments?
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Principal Display Panel
Compare to the active ingredient in Extra Strength Tylenol®*
EXTRA STRENGTH
Acetaminophen, Liquid 500 mg
Pain reliever; Fever reducer
For Ages 12 & over
Cherry flavor
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol®.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, PI 02895
CVS.com
- Product Label
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INGREDIENTS AND APPEARANCE
PAIN RELIEVER FEVER REDUCER EXTRA STRENGTH
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-878 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-878-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/30/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 04/30/2018 Labeler - CVS Pharmacy (062312574)