Extra Strength Pain Reliever: Package Insert and Label Information

EXTRA STRENGTH PAIN RELIEVER- aspirin, acetaminophen, salicylamide and caffeine tablet
Redicare LLC

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

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

Box
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 162 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 110 mg
SALICYLAMIDE (SALICYLAMIDE) SALICYLAMIDE 152 mg
CAFFEINE (CAFFEINE) CAFFEINE 32.4 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
FD&C YELLOW NO. 6
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color orange (Rose Orange) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code FR2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71105-242-68 100 TABLET in 1 CARTON None
Image of Product
(click image for full-size original)
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)

Revised: 07/2021 Redicare LLC

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