PAIN RELIEVER- acetaminophen, aspirin, salicylamide 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 100 MG, ASPIRIN 162 MG, SALICYLAMIDE 152 MG, CAFFEINE (ADJUVANT) 32.4 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 4 hours as

 needed, with a full glass of water. Do not exceed 6 tablets in any 24 hour period.

Children under 12 years: Consult a doctor.

Inactive Ingredients:

FD&C yellow #6, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch and stearic acid

PAIN RELIEVER BOX

Pain Reliever Packet

Pain Reliever Packet

PAIN RELIEVER 
acetaminophen, aspirin, salicylamide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67060-242
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN110 
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN162 
SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE152 
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CAFFEINE (UNII: 3G6A5W338E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colororange (ROSE ORANGE) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code FR2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67060-242-68100 in 1 CARTON04/07/2015
12 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/07/201506/04/2019
Labeler - ADVANCED FIRST AID, INC. (114477180)
Registrant - ADVANCED FIRST AID, INC. (114477180)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA SEAL CORPORATION085752004pack(67060-242)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA TAB LABORATORIES, INC.151051757manufacture(67060-242)

Revised: 6/2019
 
ADVANCED FIRST AID, INC.