ADVANCED PAIN RELIEVER- acetaminophen, aspirin, caffeine tablet

ADVANCED PAIN RELIEVER by

Drug Labeling and Warnings

ADVANCED PAIN RELIEVER by is a Otc medication manufactured, distributed, or labeled by ADVANCED FIRST AID, INC., ULTRA SEAL CORPORATION, ULTRA TAB LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT (IN EACH TABLET)- ACETAMINOPHEN 250 MG, ASPIRIN 250 MG, CAFFEINE 65 MG

PURPOSE

PAIN RELIEVER/FEVER REDUCER WITH ADJUVANT

INDICATIONS & USAGE

Uses:

temporarily relieves minor aches and pains associated with:

headaches colds toothache minor arthritis pain muscular aches menstrual cramps backache

WARNINGS

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.

PREGNANCY OR BREAST FEEDING

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

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.

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

hypromellose*, maltodextrin*, microcrystalline cellulose, polyethylene glycol*, povidone, sodium starch glycolate, starch, stearic acid, titanium dioxide*

*contains one or more of these ingredients

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADVANCED PAIN RELIEVER 
acetaminophen, aspirin, caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67060-174
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (50 MPA.S) (UNII: 1IVH67816N)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (SNOW WHITE)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	FR9
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67060-174-67	125 in 1 CARTON	08/07/2019
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 67060-174-68	50 in 1 CARTON	08/07/2019
2		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	08/07/2019

Labeler - ADVANCED FIRST AID, INC. (114477180)

Registrant - ADVANCED FIRST AID, INC. (114477180)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	pack(67060-174)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA TAB LABORATORIES, INC.		151051757	manufacture(67060-174)