UNISHIELD PAIN ACHE- aspirin, caffeine tablet, film coated

Unishield Pain Ache by

Drug Labeling and Warnings

Unishield Pain Ache by is a Otc medication manufactured, distributed, or labeled by Unishield, Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)

Aspirin 500 mg (NSAID)*

Caffeine 32.5 mg

*nonsteroidal anti-inflammatory drug

PURPOSE

Purpose

Pain reliever

Pain reliever aid

INDICATIONS & USAGE

Uses

for the temporary relief of
■ backache pain
■ muscle aches and pains
■ minor aches and pains of arthritis

WARNINGS

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert:

Aspirin may cause a severe allergic reaction which may include:

■ hives

■ shock

■ facial swelling

■ asthma (wheezing)

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

■ take more or for a longer time than directed

■ take a blood thinning (anticoagulant) or steroid drug

■ are age 60 or older

■ have 3 or more alcohol drinks every day while using this product

■ have had stomach ulcers or bleeding problems

■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

DO NOT USE

Do not use
■ if you are allergic to aspirin or any other pain reliever/fever reducer.
■ if you have ever had an allergic reaction to this product or any of its ingredients

ASK DOCTOR

Ask a doctor before use if

■ stomach bleeding warning applies to you

■ you have a history of stomach problems, such as heartburn

■ you have asthma

■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

■ you are taking a diuretic

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking a prescription drug for
■ gout
■ diabetes
■ arthritis

STOP USE

Stop use and ask a doctor if

■ an allergic reaction occurs. Seek medical help right away.

■ you experience any of the following signs of stomach bleeding: ■ vomit blood ■ have bloody or black stools ■ feel faint ■ have stomach pain that does not get better

■ ringing in the ears or a loss of hearing occurs

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ redness or swelling is present

■ new symptoms occur

These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center
(1-800-222-1222) right away.

DOSAGE & ADMINISTRATION

Directions

■ drink a full glass of water with each dose

Adults and children (12 years and over): take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours

Children under 12 years: do not use unless directed by a doctor

OTHER SAFETY INFORMATION

Other information

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

■ tamper evident sealed packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT

Inactive ingredients

corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

QUESTIONS

Questions or comments? 800-480-5855

PRINCIPAL DISPLAY PANEL

Unishield

Pain & Ache

Extra Strength Pain Relief

80 caplets / 2 Caplets Per Packet

Aspirin (NSAID) 500 mg, Caffeine 32.5 mg

Pain Reliever, Pain Reliever Aid

Pull To Open

This package is for Households Without young Children.

Fast, effective relief from tough headaches

Non-drowsy formula contains caffeine

Fast Acting Advanced Formula

Tamper Evident Unit Dose Packets

INGREDIENTS AND APPEARANCE

UNISHIELD PAIN ACHE 
aspirin, caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49314-8218
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	32.5 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	500 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE (Caplet)	Size	17mm
Flavor		Imprint Code	44;413
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49314-8218-0	40 in 1 BOX	09/26/2022
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	09/26/2022

Labeler - Unishield (790677053)

Registrant - Unifirst First Aid Corporation (832947092)