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NDC 49314-8218-00 Unishield Pain Ache 500; 32.5 mg/1; mg/1 Details
Unishield Pain Ache 500; 32.5 mg/1; mg/1
Unishield Pain Ache is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Unishield. The primary component is ASPIRIN; CAFFEINE.
Product Information
NDC | 49314-8218 |
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Product ID | 49314-8218_e7a2b4f5-a0ef-741c-e053-2995a90af8e7 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Unishield Pain Ache |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Aspirin, Caffeine |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET, FILM COATED |
Route | ORAL |
Active Ingredient Strength | 500; 32.5 |
Active Ingredient Units | mg/1; mg/1 |
Substance Name | ASPIRIN; CAFFEINE |
Labeler Name | Unishield |
Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [E |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part343 |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 49314-8218-00 (49314821800)
NDC Package Code | 49314-8218-0 |
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Billing NDC | 49314821800 |
Package | 40 PACKET in 1 BOX (49314-8218-0) / 2 TABLET, FILM COATED in 1 PACKET |
Marketing Start Date | 2022-09-26 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e7137224-88fd-0bc4-e053-2a95a90a9313 Details
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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)
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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.
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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 |
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Labeler - Unishield (790677053) |
Registrant - Unifirst First Aid Corporation (832947092) |