PAIN AID ESF- acetaminophen, aspirin, 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:
Zee Medical Inc
INN (International Name):
ACETAMINOPHEN
Composition:
ACETAMINOPHEN 250 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose-Pain reliever, Fever Reducer Uses ■ temporarily relieves pain due to: ■ headache ■ muscular aches ■ colds ■ flu ■ temporarily reduces fever
Authorization status:
OTC monograph not final
Authorization number:
35418-560-02, 35418-560-67, 35418-560-68, 35418-560-70

PAIN AID ESF- acetaminophen, aspirin, caffeine tablet

Zee Medical 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.

----------

Drug Facts

Active Ingredient (in each tablet) Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg

Purpose-Pain reliever, Fever Reducer

Uses

■ temporarily relieves pain due to:

■ headache ■ muscular aches ■ colds ■ flu

■ temporarily reduces fever

Directions

adults: take 2 tablets every 6 hours, not more than 8 tablets in

24 hours

children under 12 years: ask a doctor

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 ■ facial swelling ■ asthma (wheezing) ■ shock

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 a

nonsteroidal anti-inflammatory drug (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 heart beat.

Do not use

■ if you have ever had an allergic reaction to 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.

Stop use and ask a doctor if

■ an allergic reaction occurs. Seek medical help right away.

■ 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 more than 10 days

■ fever gets worse or lasts more than 3 days

■ redness or swelling is present in the painful area

■ any new symptoms appearAsk a doctor before use if you are taking a prescription drug for diabetes,

gout, or arthritis■ stomach bleeding warning applies to you■ you have a history of stomach problems,

such as heartburn you have asthma, high blood pressure, heart disease, live rdisease, or kidney

disease■ you are taking a diuretic

If pregnant or breast-feeding baby, ask a health professional

before use

KEEP OUT OF REACH OF CHILDREN. In case of overdose,

get medical help or contact a Poison Control Center right away.

Prompt medical attention is critical for adults as well as for

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

Inactive ingredients cellulose*, hydroxypropyl

methylcellulose, maltodextrin*, polyethylene glycol, povidone,

propylene glycol*, sodium lauryl sulfate*, sodium starch

glycolate, starch, stearic acid, titanium dioxide

*contains one or more of these ingredients

PAIN AID ESF

acetaminophen, aspirin, caffeine tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:35418 -56 0

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

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

STARCH, CO RN (UNII: O8 232NY3SJ)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

PO LYETHYLENE GLYCO L 3 0 0 (UNII: 56 55G9 Y8 AQ)

PO VIDO NE K2 9 /3 2 (UNII: 39 0 RMW2PEQ)

Zee Medical Inc

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 (sno w white)

S core

no sco re

S hap e

ROUND (ZEE;ESF)

S iz e

12mm

Flavor

Imprint Code

ZEE;ESF

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:35418 -56 0 -6 8

50 in 1 CARTON

0 6 /12/20 12

1

NDC:35418 -56 0 -6 7

125 in 1 CARTON

1

NDC:35418 -56 0 -70

12 in 1 CARTON

1

NDC:35418 -56 0 -0 2

2 in 1 PACKET; 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 6 /12/20 12

Labeler -

Zee Medical Inc (009645623)

Registrant -

Ultra Seal Corporation (085752004)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ultratab Labo rato ries, Inc.

1510 51757

ma nufa c ture (35418 -56 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ultra Seal Co rpo ratio n

0 8 57520 0 4

re pa c k(35418 -56 0 )

Revised: 10/2019

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