Your browser does not support JavaScript! EXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY (ACETAMINOPHEN) LIQUID [CVS]
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EXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY (acetaminophen) liquid
[CVS]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

Active Ingredients

Acetaminophen 500 mg

Purpose

Acetaminophen....................Pain reliever/Fever reducer

Uses

• temporarily relieves minor aches and
pains due to: • headache • muscular aches
• backache • minor pain of arthritis
• the common cold • toothache
• premenstrual and menstrual cramps
• temporarily reduces fever

Warnings

Liver warning: This product contains
acetaminophen. Severe liver damage may
occur if you take: • more than 4 doses
(8 tablespoonfuls or 120 mL) in 24 hours,
which is the maximum daily amount • with
other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday while
using this product

Do Not Use

• with any other drug containing
acetaminophen (prescription or non-prescription).
If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacist

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

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.

If pregnant or breast-feeding

ask a health professional before use.

Keep this and all drugs out of the 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 immediately. Quick medical
attention is critical for adults as well as for
children even if you do not notice any signs or
symptoms.

Directions

• do not take more than directed
(see overdose warning)
• use only enclosed measuring cup designed
for use with this product. Do not use any
other dosing device.

adults and children 12 years and over                            • take 2 tablespoons (tbsp) or 1 oz in dose cup
                                                                                                 provided every 4 to 6 hrs while symptoms last
children under 12 years                                                     • do not take more than 8 tablespoons (tbsp) or
                                                                                                 4 oz in 24 hrs
                                                                                              • do not take more than 10 days unless directed
                                                                                                by a doctor
                                                                                              • do not use this adult product in children under
                                                                                                12 years of age; this will provide more than the
                                                                                                recommended dose (overdose) and may
                                                                                                cause liver damage

Other Information

each tablespoon contains: sodium 9 mg
• store at controlled room temperature
• dosage cup provided

Inactive Ingredients

citric acid, flavors, high fructose corn syrup,
polyethylene glycol, propylene glycol,
purified water, red 33, red 40, saccharin
sodium, sodium benzoate, sorbitol

Principal Display Panel

CVS Pharmacy
Extra Strength Pain Relief
Adult Liquid
Acetaminophen   Pain Reliever, Fever Reducer
Rapid Burst Cherry Flavor
8 fl oz (237 mL)

image of  label


EXTRA STRENGTH ACETAMINOHPEN  ADULT RAPID BURST CHERRY
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-550
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen500 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
HIGH FRUCTOSE CORN SYRUP 
POLYETHYLENE GLYCOL 300 
PROPYLENE GLYCOL 
WATER 
D&C RED NO. 33 
FD&C Red No. 40 
SACCHARIN SODIUM ANHYDROUS 
SODIUM BENZOATE 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Tynelol Type Cherry Rapid Blast Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-550-88237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/02/2009
Labeler - CVS (062312574)
Registrant - Aaron Industries, Inc. (101896231)
Establishment
NameAddressID/FEIBusiness Operations
Aaron Industries, Inc.101896231manufacture, analysis

Revised: 11/2009
 
CVS

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