UNISHIELD PAIN ZAPPER- acetaminophen, aspirin, caffeine, salicylamide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

Available from:

Unishield

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Pain reliever/fever reducer Pain reliever/fever reducer Adjuvant Pain reliever/fever reducer Uses t emporarily relieved minor aches and pains associated with ■ headaches ■ muscular aches ■ minor arthritis pain ■ back pain ■ colds ■ toothache ■ menstrual cramps Temporarily reduces fever. 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) 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

UNISHIELD PAIN ZAPPER- ACETAMINOPHEN, ASPIRIN, CAFFEINE,
SALICYLAMIDE TABLET
UNISHIELD
_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._
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UNISHIELD PAIN ZAPPER
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH TABLET)_
Aspirin (NSAID)* 162 mg
Caffeine 32.4 mg
Salicylamide (NSAID)* 152 mg
*nonsteroidal anti-inflammatory drug
_PURPOSE_
Pain reliever/fever reducer
Pain reliever/fever reducer
Adjuvant
Pain reliever/fever reducer
_USES_
t EMPORARILY RELIEVED MINOR ACHES AND PAINS ASSOCIATED WITH
■ headaches ■ muscular aches ■ minor arthritis pain ■ back
pain ■ colds ■
toothache ■ menstrual cramps
TEMPORARILY REDUCES FEVER.
_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 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 bl