PAIN RELIEVER 2- pain reliever tablet

Pain Reliever 2 by

Drug Labeling and Warnings

Pain Reliever 2 by is a Otc medication manufactured, distributed, or labeled by Redicare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (in each tablet)

Acetaminophen 250 mg

Aspirin 250 mg

Caffeine 65 mg

Purpose

pain reliever/fever reducer, adjuvant

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 chickenpox 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 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 ■ with large amounts of caffeinated products

Ask a doctor before use if you have:

■ asthma, liver, kidney, high blood pressure or heart disease ■ stomach problems (such as heartburn, upset or painful stomach) ■ gastric ulcers ■ bleeding problems ■ taking a diuretic ■ or if the stomach bleeding warning applies to you

Ask a doctor or pharmacist before use if

you are taking a prescription drug for ■ anticoagulation (thinning of blood) ■ diabetes ■ gout ■ arthritis ■ with other drugs or conditions

When using this product

do not exceed the recommended dose.

Stop use and ask a doctor if:

■ ringing in the ears or loss of hearing occurs ■ pain or fever persists or worsens ■ new symptoms occur ■ allergic reaction, 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 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 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

Other Information:

■ Tamper Evident. Do not use if a 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:

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

PAIN RELIEVER 2 
pain reliever tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71105-174
Route of Administration	ORAL

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

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

Product Characteristics
Color	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: 71105-174-68	50 in 1 BOX	01/03/2020
1	NDC: 71105-174-02	2 in 1 PACKAGE; 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	01/03/2020

Labeler - Redicare LLC (800149346)

Establishment
Name	Address	ID/FEI	Business Operations
Redicare LLC		800149346	repack(71105-174) , relabel(71105-174)