TOPCARE PAIN RELIEF- acetaminophen tablet 
Topco Associates LLC

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.

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Topco Associates LLC. Pain Relief Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 4,000 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
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.
if you have ever had an allergic reaction to this product or any of its ingredients

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 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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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)

adults and children

12 years and over

take 2 caplets every 6 hours while symptoms last
do not take more than 6 caplets in 24 hours, unless directed by a doctor
do not use for more than 10 days unless directed by a doctor

children under

12 years

ask a doctor

Other information

store at 20-25ºC (68-77ºF)

Inactive ingredients

carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain one or more of these ingredients

Questions or comments?

1-888-423-0139

Principal Display Panel

EXTRA STRENGTH

Pain Relief

ACETAMINOPHEN 500 mg

Pain Reliever / Fever Reducer

For Adults

SEE NEW WARNINGS

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

COMPARE TO EXTRA STRENGTH TYLENOL® CAPLETS active ingredient

actual size

150 CAPLETS

TopCare Pain Relief Image 1
TopCare Pain Relief Image 2
TopCare Pain Relief Image 3
TOPCARE PAIN RELIEF 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:36800-484
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
STARCH, CORN 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
POVIDONES 
STEARIC ACID 
CROSCARMELLOSE SODIUM 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (caplet) Size16mm
FlavorImprint Code L484
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-484-761 in 1 CARTON
1120 in 1 BOTTLE
2NDC:36800-484-621 in 1 CARTON
224 in 1 BOTTLE
3NDC:36800-484-711 in 1 CARTON
350 in 1 BOTTLE
4NDC:36800-484-781 in 1 CARTON
4100 in 1 BOTTLE
5NDC:36800-484-90500 in 1 BOTTLE
6NDC:36800-484-822 in 1 CARTON
6100 in 1 BOTTLE
7NDC:36800-484-47150 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/15/1987
Labeler - Topco Associates LLC (006935977)

Revised: 12/2014
Document Id: deb1c8c7-c206-4d3a-9309-ebac58eb3912
Set id: 6036c15b-1168-4103-9471-6a74a2140e53
Version: 6
Effective Time: 20141215
 
Topco Associates LLC