EXTRA STRENGTH HEADACHE RELIEF- acetaminophen, aspirin, caffeine tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Available from:
Family Dollar Services Inc
INN (International Name):
ACETAMINOPHEN
Composition:
ACETAMINOPHEN 250 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever Pain reliever Pain reliever aid - temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches sinusitis toothache premenstrual and menstrual cramps - headache - a cold - arthritis - muscular aches - sinusitis - toothache - premenstrual and menstrual cramps
Authorization status:
OTC monograph not final
Authorization number:
55319-159-12

EXTRA STRENGTH HEADACHE RELIEF- acetaminophen, aspirin, caffeine tablet, film

coated

Family Dollar Services Inc

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.

----------

Family Wellness 44-159B

Active ingredients (in each tablet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Uses

temporarily relieves minor aches and pains due to:

headache

a cold

arthritis

muscular aches

sinusitis

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

hives

shock

facial swelling

asthma (wheezing)

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

more than 8 tablets 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, occasionaly, rapid

heartbeat.

Do not use

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

reducer

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

stomach bleeding warning applies to you

you have a history of stomach problems, such as heartburn

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

you have asthma

you are taking a diuretic

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 a doctor if

you experience any of the following signs of stomach bleeding:

feel faint

have bloody or black stools

vomit blood

have stomach pain that does not get better

an allergic reaction occurs. Seek medical help right away.

any new symptoms appear

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

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 (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.

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 tablets every 6 hours

do not take more than 8 tablets in 24 hours

children under 12 years: ask a doctor

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol,

sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

FAMILY

wellnes s

COMPARE TO THE ACTIVE

INGREDIENTS OFEXCEDRIN

EXTRA STRENGTH

Extra Strength

Headache Relief

Acetaminophen,

Aspirin (NSAID) and Caffeine

Pain Reliever/Pain Reliever Aid

100 TABLETS

100% SATISFACTION

OR YOUR MONEY BACK

GUARANTEED

This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the

registered trademark Excedrin Extra Strength.

50844 REV0713A15912

Not 100% satisfied?

Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt)

or exchange.

DISTRIBUTED BY:

®

FAMILY DOLLAR SERVICES, INC.,

10401 MONROE RD,

MATTHEWS, NC 28105 USA

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

BROKEN OR MISSING

Family Wellness 4 4 -159B

EXTRA STRENGTH HEADACHE RELIEF

acetaminophen, aspirin, caffeine tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55319 -159

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

CRO SPO VIDO NE (UNII: 2S78 30 E56 1)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

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

PO LYETHYLENE GLYCO LS (UNII: 3WJQ0 SDW1A)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

13mm

Flavor

Imprint Code

44;159

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:55319 -159 -

1 in 1 CARTON

11/17/19 9 2

0 7/0 8 /20 19

1

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

Pro duc t

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

11/17/19 9 2

0 7/0 8 /20 19

Family Dollar Services Inc

Labeler -

Family Dollar Services Inc (024472631)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(55319 -159 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(55319 -159 )

Revised: 7/2016

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