EXTRA STRENGTH PAIN RELIEVER tablet

Extra Strength Pain Reliever by

Drug Labeling and Warnings

Extra Strength Pain Reliever by is a Otc medication manufactured, distributed, or labeled by Redicare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Acetaminophen 110 mg .....................................................................................pain reliever/fever reducer

Aspirin 162 mg .....................................................................................................pain reliever/fever reducer

Caffeine 32.4 mg...............................................................................................................................adjuvant

Salicylamide 152 mg............................................................................................pain reliever/fever reducer

Uses:

temporarily relieves minor aches and pains associated with ■ headaches ■ colds ■ a toothache ■ minor arthritis pain ■ muscular aches ■ menstrual cramps ■ a 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 a non-steroidal anti-inflammatory drug (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 a 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 a 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 a 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 4 hours as needed, with a full glass of water. Do not exceed 6 tablets in any 24 hour period
Children under 12 years: Ask a doctor

Other Information:

■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) ■ Avoid excessive heat and humidity

Inactive Ingredients:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELIEVER 
extra strength pain reliever tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71105-242
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	162 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	110 mg
SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC)	SALICYLAMIDE	152 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	32.4 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	orange (Rose Orange)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	FR2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71105-242-68	100 in 1 CARTON; Type 0: Not a Combination Product	10/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	10/01/2017

Labeler - Redicare LLC (800149346)

Establishment
Name	Address	ID/FEI	Business Operations
Redicare LLC		800149346	repack(71105-242)