Drug Labeling and Warnings

Drug Details [pdf]

ADVANCED PAIN RELIEVER- acetaminophen, aspirin 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.

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

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

Warnings:

Reye's syndrome:

Children and teenagers should not use this medicine for chicken pox or flu symptoms before

a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Liver Warning:

This product contains Acetaminophen. Severe liver damage may occur if:

you take more than 8 tablets in 24 hours you take with other drugs containing acetaminophen (prescription

or non-prescription)

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

Stomach Bleeding Warning:

This product contains nonsteroidal anti-inflammatory drugs (NSAIDs)

which may cause stomach bleeding. The chance is higher if you:

have had stomach ulcers or bleeding

problems

take a blood thinning (anticoagulant) or steroid drug are age 60 or older have 3 or more

alcoholic drinks every day while using this product

take with other drugs containing an NSAID you take more

or for a longer time than directed

Do not use:

if you are allergic to aspirin 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

with any other product containing acetaminophen

Ask doctor before using if you have:

asthma stomach problems (such as heartburn, upset stomach or

stomach pain)

gastric ulcers bleeding problems

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.

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

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

SPECIFIC-ALLY 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.

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: Consult a doctor.

Inactive Ingredients:

magnesium stearate, microcrystalline cellulose, povidone,

sodium starch glycolate, starch and stearic acid

Mfd For: Advanced First Aid, Baltimore, MD 21237

ADVANCED PAIN RELIEVER BOX

ADVANCED PAIN RELIEVER 
acetaminophen, aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67060-560
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
CAFFEINE (UNII: 3G6A5W338E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorwhite (SNOW WHITE) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code FR9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67060-560-68100 in 1 CARTON04/07/201508/26/2019
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC: 67060-560-67250 in 1 CARTON04/07/2015
22 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/07/201508/26/2019
Labeler - ADVANCED FIRST AID, INC. (114477180)
Registrant - ADVANCED FIRST AID, INC. (114477180)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA SEAL CORPORATION085752004pack(67060-560)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA TAB LABORATORIES, INC.151051757manufacture(67060-560)

Revised: 8/2019
 
ADVANCED FIRST AID, INC.