ADVANCED PAIN RELIEVER- 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:
ADVANCED FIRST AID, INC.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
PAIN RELIEVER/FEVER REDUCER WITH ADJUVANT Uses: temporarily relieves minor aches and pains associated with: • headaches • colds • toothache • minor arthritis pain • muscular aches • menstrual cramps • backache
Authorization status:
OTC monograph not final
Authorization number:
67060-117-67

ADVANCED PAIN RELIEVER- acetaminophen, aspirin, caffeine tablet

ADVANCED FIRST AID, 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.

----------

ACTIVE INGREDIENT (IN EACH TABLET)- ACETAMINOPHEN 250 MG, ASPIRIN 250 MG,

CAFFEINE 65 MG

PAIN RELIEVER/FEVER REDUCER WITH ADJUVANT

Us es :

temporarily relieves minor aches and pains associated with:

headaches colds toothache minor arthritis pain muscular aches menstrual cramps backache

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

or others)

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

you 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 medcations, foods or beverages while taking this product because too much

caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Do not use:

with any other product containing acetaminophen (prescription or nonprescription) this will provide

more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns

with any other pain reliever/fever reducer

if you have ever had an allergic reaction to 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

Ask doctor before using if you have:

stomach problems (such as heartburn, upset stomach or stomach pain)

stomach bleeding warning applies to you

gastric ulcers

bleeding problems

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

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

under a doctor's care for any serious condition

taking any other drug

When using this product do not exceed recommended dose.

Stop use and ask a doctor if:

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, have stomach pain that does not get better.

These are signs of stomach bleeding.

an allerginc reaction occurs

Seek medical help right away.

If pregnant or breast-feeding baby, 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. 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:Take 2 tablets every 6 hours as needed, with a full

glass of water. Do not exceed 8 tablets in any 24 hour period.

Children under 12 years: Ask a doctor.

hypromellose*, maltodextrin*, microcrystalline cellulose, polyethylene glycol*, povidone, sodium

starch glycolate, starch, stearic acid, titanium dioxide*

*contains one or more of these ingredients

ADVANCED PAIN RELIEVER

acetaminophen, aspirin, caffeine tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 70 6 0 -117

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

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

ASPIRIN

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

CAFFEINE

Inactive Ingredients

Ingredient Name

Stre ng th

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

PO VIDO NE K3 0 (UNII: U725QWY32X)

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

HYPRO MELLO SE 2 9 10 ( 3 MPA.S) (UNII: 0 VUT3PMY8 2)

HYPRO MELLO SE 2 9 10 ( 6 MPA.S) (UNII: 0 WZ8 WG20 P6 )

HYPRO MELLO SE 2 9 10 ( 50 MPA.S) (UNII: 1IVH6 78 16 N)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

ADVANCED FIRST AID, INC.

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

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

white (SNOW 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:6 70 6 0 -117-6 7

250 in 1 CARTON

0 8 /0 7/20 19

1

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 8 /0 7/20 19

Labeler -

ADVANCED FIRST AID, INC. (114477180)

Registrant -

ADVANCED FIRST AID, INC. (114477180)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

ULTRA SEAL CORPORATION

0 8 57520 0 4

pa c k(6 70 6 0 -117)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

ULTRA TAB LABORATORIES, INC.

1510 51757

ma nufa c ture (6 70 6 0 -117)

Revised: 8/2019

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