HEADACHE RELIEF EXTRA STRENGTH- acetaminophen, aspirin, caffeine tablet

USA - engelsk - NLM (National Library of Medicine)

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Preparatomtale Preparatomtale (SPC)

14-10-2019

Aktiv ingrediens:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Tilgjengelig fra:
TOP CARE (Topco Associates LLC)
INN (International Name):
ACETAMINOPHEN
Sammensetning:
ACETAMINOPHEN 250 mg
Administreringsrute:
ORAL
Resept typen:
OTC DRUG
Indikasjoner:
Pain reliever Pain reliever Pain reliever aid - temporarily relieves minor aches and pains due to headache a cold ​ arthritis muscular aches  ​​​ toothache premenstrual and menstrual cramps - headache - a cold ​ - arthritis - muscular aches  ​​​ - toothache - premenstrual and menstrual cramps
Autorisasjon status:
OTC monograph not final
Autorisasjonsnummer:
36800-525-10

HEADACHE RELIEF EXTRA STRENGTH- acetaminophen, aspirin, caffeine tablet

TOP CARE (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.

----------

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpos es

Pain reliever

Pain reliever

Pain reliever aid

Us es

temporarily relieves minor aches and pains due to

headache

a cold

arthritis

muscular aches

toothache

premenstrual and menstrual cramps

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like

symptoms should not use this product. When using this product, if changes in behavior with nausea and

vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a

rare but serious illness

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.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

hives

facial swelling

shock

asthma (wheezing)

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

more than 8 caplets in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach

bleeding. The chance is higher if you:

are age 60 or older

have had stomach ulcers or bleeding problems

take a blood thinning (anticoagulant) or steroid drug

take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen,

or others)

have 3 or more alcoholic drinks every day while using this product

take more or for a longer time than directed

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of

coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product

because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid

heartbeat.

Do not use

if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever

reducer

with any other drug containing acetaminophen (prescription or nonprescription). 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

stomach bleeding warning applies to you

you have asthma

you are taking a diuretic

you have a history of stomach problems, such as heartburn

you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout, or arthritis

taking any other drug or are under a doctor’s care for any serious condition

Stop use and ask doctor if

an allergic reaction occurs. Seek medical help right away.

any new symptoms appear

you experience any of the following signs of stomach bleeding

feel faint

vomit blood

have bloody or black stools

have stomach pain that does not get better

ringing in the ears or loss of hearing occurs

pain gets worse or lasts for more than 10 days

fever gets worse or lasts for more than 3 days

painful area is red or swollen

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months

of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the

unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. 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 use more than directed

drink a full glass of water with each dose

adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in

24 hours

children under 12 years: do not use unless directed by a doctor

Other information

store between 20º-25ºC (68º-77ºF)

Inactive ingredients

carnauba wax**, colloidal silicon dioxide, corn starch, hypromellose, microcrystalline cellulose,

mineral oil**, polyethylene glycol**, povidone, sodium starch glycolate**, stearic acid, talc**, titanium

dioxide

**contains one or more of these ingredients

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

COMPARE TO EXCEDRIN® EXTRA STRENGTH ACTIVE INGREDIENTS

EXTRA STRENGTH

Headache Relief

ACETAMINOPHEN, ASPIRIN (NSAID) & CAFFEINE

PAIN RELIEVER PAIN RELIEVER AID

CAPLETS

†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor

of Excedrin® Extra Strength.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN

OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

QUESTIONS? 1-888-423-0139

topcare@topco.com www.topcarebrand.com

Package Label

TOPCARE HEALTH Extra Streng th Headache Relief

HEADACHE RELIEF EXTRA STRENGTH

acetaminophen, aspirin, caffeine tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:36 8 0 0 -525

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

250 mg

ASPIRIN (UNII: R16 CO5Y76 E) (ASPIRIN - UNII:R16 CO5Y76 E)

ASPIRIN

250 mg

CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E)

CAFFEINE

6 5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CARNAUBA WAX (UNII: R12CBM0 EIZ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STARCH, CO RN (UNII: O8 232NY3SJ)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

MINERAL O IL (UNII: T5L8 T28 FGP)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

CAPSULE

S iz e

17mm

Flavor

Imprint Code

TCL370 ;S53

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:36 8 0 0 -525-

1 in 1 BOX

0 7/15/20 16

1

10 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

TOP CARE (Topco Associates LLC)

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part343

0 7/15/20 16

Labeler -

T OP CARE (T opco Associates LLC) (006935977)

Revised: 10/2019

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