Label: UNISHIELD PAIN ZAPPER- acetaminophen, aspirin, caffeine, salicylamide tablet
- NDC Code(s): 49314-8113-3
- Packager: Unishield
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated July 8, 2021
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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 and Salicylamide may cause a severe allergic reaction which may include:
■ hives ■ facial swelling ■ asthma (wheezing) ■ shock
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening ■ blisters ■ rash
If a skin or allergic reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
Stomach bleeding warning: This product contains nonsteroidal anti-inflammatory drugs (NSAIDs), which may cause severe stomach bleeding. The chance is higher if you:
■ are age 60 or older
■ have had stomach ulcers or bleeding problems
■ take a blood thinning (anticoagulant) or steroid drug
■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
■ have 3 or more alcoholic drinks every day while using this product
■ take more or for a longer time than directed
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine- containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat
DO NOT USE
Do not use
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a
drug contains acetaminophen, ask a doctor or pharmacist.
■ for pain for more than 10 days unless directed by a doctor
■for more than 3 days for fever unless directed by a doctor
■ with any other pain reliever/fever reducerl)
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- ASK DOCTOR/PHARMACIST
- WHEN USING
Stop use and ask a doctor if
■ you experience any of the following signs of stomach bleeding: ■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better
■ symptoms do not improve
■ pain or fever gets worse
■ ringing in the ears or loss of hearing occurs
■ new symptoms occur
PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use aspirin and salicylamide during the last 3 months of pregnancy unless definitely 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.
Taking more than the recommended dose (overdose) may cause liver damage.
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.
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
Unishield Pain Zapper Label
Extra Strength Pain Relief
100 Tablets/ 2 Tablets Per Packet
Acetaminophen 110 mg. Aspirin (NSAID) 162 mg
Caffeine 32.4 mg. Salicylamide (NSAID) 152 mg
Pull To Open
This Package is for Households wirhout 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 ZAPPER
acetaminophen, aspirin, caffeine, salicylamide tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49314-8113 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 162 mg SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE 152 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 110 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 32.4 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color orange Score no score Shape ROUND Size 11mm Flavor Imprint Code FR;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49314-8113-3 50 in 1 BOX 03/01/2021 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 not final part343 03/01/2021 Labeler - Unishield (790677053) Registrant - Unifirst First Aid Corporation (832947092) Establishment Name Address ID/FEI Business Operations Prestige Packaging 080667761 repack(49314-8113)