FDA Label for Vica-cet
View Indications, Usage & Precautions
Vica-cet Product Label
The following document was submitted to the FDA by the labeler of this product Provision Medical Products. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Indications & Usage
Uses:
for temporary relief of mild to moderate pain
associated with BACKACHE, headache, colds. toothache, minor arthritis pain, muscular aches, menstrual cramps
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a
health professional before use. IT IS
ESPECIALLY IMPORTANT NOT TO USE
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.
Otc - 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 right
away. Prompt medical attention is
critical for adults as well as for children
even if you do not notice any signs or
symptoms.
Warnings
Warnings:
Reye's syndrome: Children and teenagers should not
use this medicine for chicken pox or u symptoms
before a doctor is consulted about Reye's syndrome, a
rare but serious illness reported to be associated with
aspirin.
Allergy Alert: Do not take this product if after
taking a pain reliever or fever reducer you ever had • hives • facial swelling • asthma • shock
Alcohol Warning: If you consume 3 or more
alcoholic drinks every day, ask your doctor whether you
should take acetaminophen and aspirin or other pain
relievers/fever reducers. Acetaminophen and aspirin may
cause liver damage and stomach bleeding.
Ask a doctor before use if you have: • the worst headache of your life • ulcers
• fever and sti neck • asthma
• bleeding problems • liver disease
• renal disease
When using this product:
• limit the use of caffeine containing medications,
foods, or beverages while taking this product
because too much caFFeine may cause
nervousness, sleeplessness, irritability and,
occasionally, rapid heart beat.
Stop use and ask a doctor if:
• headache pain worsens or continues for more than 48 hours
• new or unexpected symptoms occur
• ringing in the ears or loss of hearing occur
Dosage & Administration
Directions:
Adults and children 12 years of age, no to exceed 8 tablets in 24 hours, or as directed by a doctor.
Children under 12 years: Do not give to children under 12 unless directed by a doctor.
Inactive Ingredient
Inactive Ingredients:
hydroxypropyl methylcellulose, maltodextrin,microcrystalline cellulose,polyethylene glycol
povidone, sodium starch glycolate, starch, and stearic acid
USP.
Otc - Active Ingredient
ACTIVE INGREDIENT-ACETAMINOPHEN 250 MG, MAGNESIUM SALICYLAYE 250 MG,CAFFEINE 50 mg
Otc - Purpose
PAIN RELIEVER, FEVER REDUCER WITH ADJUVANT
Package Label.Principal Display Panel
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