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

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:
Mechanical Servants LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
temporarily relieves minor aches and pains due to: backache headaches colds muscular aches minor arthritis pain menstrual cramps Temporarily reduces fever.
Authorization status:
OTC monograph not final
Authorization number:
29485-0752-6

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

Mechanical Servants 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.

----------

Extra Strength Headache Relief

Active ingredient (in each

tablet)

Purposes

Acetaminophen 250 mg

Pain reliever/fever

reducer

Aspirin (NSAID)* 250

Pain reliever/fever

reducer

Caffeine 65 mg

Pain reliever aid

* nonsteroidal anti-inflammatory drug

Us e

temporarily relieves minor aches and pains due to:

backache

headaches

colds

muscular aches

minor arthritis pain

menstrual cramps

Temporarily reduces fever.

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 behaviour 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

facial swelling

asthma (wheezing)

shock

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.

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 (perscription or nonperscription). If you are not sure

wether a drug contains acetaminophen, ask a doctor or pharmacist.

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]

take more or for a longer time than directed

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

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, iritability, sleeplessness, and occasionally rapid heart beat.

Do not use

if you are allergic to aspirin or any other pain reliever / fever reducer

with any other pain reliever/fever reducer

for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor

if you have ever had an allergic reaction to any other pain reliever-fever reducer

with any other product containing acetaminophen this will provide more than the recommended dose

(overdose) of acetaminophen and could cause serious health concerns

Ask a doctor before using if:

you have liver disease

the stomach bleeding warning applies to you

you have a history of stomach problems (such as heartburn, upset stomach or stomach pain)

you have high blood pressure, heart, liver 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

anticoagulation (thinning of blood)

diabetes

gout

arthritis

When using this product do not exceed recommended dose.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if:

an allergic reaction occurs. Seek medical help right away.

ringing in the ears or loss of hearing occurs

pain or fever persists or gets worse

new symptoms occur

redness or swelling is present

you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.

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 SPECIFICALLY 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(1-800-222-1222). Prompt medical attention is critical for adults as well as for

children even if you do not notice any signs or symptoms.

Directions

adults and children 12 years of age and older:

2 tablets as needed for pain every 6 hours.

Do not exceed 8 tablets in 24 hours or as directed by a doctor.

children under 12 years: consult a doctor

Other information

TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN, CUT OR OPENED

store at controlled room temperature 15°-30°C (59°-86°F)

avoid excessive heat and humidity

Inactive ingredients

Hydroxypropyl Methylcellulose*, Maltodextrin*, Microcrystalline Cellulose, Polyethylene Glycol*,

Povidone, Sodium Starch Glycolate, Starch, Stearic Acid, Titanium Dioxide*

*contains one or more of these ingredients

Questions or comments?

1-844-428-2538

Manufactured by Ultratab Laboratories, Inc

Repackaged and distributed by

Convenience Valet

, Glendale Heights, IL 60139

PRINCIPAL DISPLAY PANEL - 6 Tablet Pouch Package

EXTRA STRENGTH HEADACHE RELIEF

acetaminophen, aspirin, and caffeine tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:29 48 5-0 752

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Aceta mino phen (UNII: 36 2O9 ITL9 D) (Acetamino phen - UNII:36 2O9 ITL9 D)

Ac e ta mino phe n

250 mg

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

Aspirin

250 mg

Ca ffeine (UNII: 3G6 A5W338 E) (Caffeine - UNII:3G6 A5W338 E)

Ca ffe ine

6 5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

Hypro mello se, Unspecified (UNII: 3NXW29 V3WO)

Ma lto dextrin (UNII: 7CVR7L4A2D)

Micro crysta lline Cellulo se (UNII: OP1R32D6 1U)

Po lyethylene Glyco l, Unspecified (UNII: 3WJQ0 SDW1A)

Po vido ne, Unspecified (UNII: FZ9 8 9 GH9 4E)

Stea ric Acid (UNII: 4ELV7Z6 5AP)

Tita nium Dio xide (UNII: 15FIX9 V2JP)

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

STARCH, CO RN (UNII: O8 232NY3SJ)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

11mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:29 48 5-0 752-6

3 in 1 PACKAGE

0 1/31/20 13

1

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 1/31/20 13

Mechanical Servants LLC

Labeler -

Mechanical Servants LLC (005530951)

Revised: 3/2019

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