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FDA-Requested Adult
Drug Facts Label
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Editor's note:
Reproduced from an FDA template for the modified
NSAID adult Drug Fact label. This template and the
pediatric Drug Facts label and Principal Display
Panel templates are available on the CDER
website.
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Drug
Facts
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Active ingredient (in each
[insert dosage unit]) Purpose
[insert active ingredient] XXX mg
(NSAID)*...............................................................Pain
reliever/fever reducer
* nonsteroidal anti-inflammatory drug
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Uses
? [add NDA approved
uses]
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Warnings
Allergy alert: [insert active ingredient]
may cause a severe allergic reaction, especially in
people allergic to aspirin. Symptoms may include:
? hives
? facial
swelling ?
asthma
(wheezing)
? shock
? skin
reddening ?
rash
? blisters
If an
allergic reaction occurs, stop use and seek medical
help right away.
Stomach
bleeding warning: This product contains a
nonsteroidal anti-inflammatory drug (NSAID), which
may cause 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 an NSAID [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
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Do not
use
? if you have ever
had an allergic reaction to any other pain
reliever/fever reducer
? right before or
after heart surgery
? with any other
drug containing an NSAID (prescription or
nonprescription). Ask a doctor or pharmacist before
using with other drugs if you are not sure.
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Ask a
doctor before use if you have
? problems or
serious side effects from taking pain relievers or
fever reducers
? stomach problems
that last or come back, such as heartburn, upset
stomach, or stomach pain
? ulcers
? bleeding
problems
? high blood
pressure
? heart or kidney
disease
? taken a
diuretic
? reached age 60 or
older
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Ask a
doctor or pharmacist before use if you are
? under a doctor's
care for any serious condition
? taking a blood
thinning (anticoagulant) or steroid drug
? taking any other
drug
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When
using this product
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? take with
food or milk if stomach upset occurs
? taking
longer than 10 days or more than the recommended dose
may increase the risk of heart attack or
stroke
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Stop use
and ask a doctor if
? you feel faint, vomit blood, or have bloody or
black stools. These are signs of stomach
bleeding.
? pain gets worse or lasts more than 10 days
? fever gets worse or lasts more than 3 days
? stomach pain or upset gets worse or lasts
? redness or swelling is present in the painful
area
? any new symptoms appear
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If
pregnant or breast-feeding, ask a health
professional before use. It is especially important
not to use [NSAID active ingredient] 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. In case of
overdose, get medical help or contact a Poison
Control Center right away.
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Directions
? do not take more than directed
? the smallest effective dose should be used
? do not take longer than 10 days, unless directed
by a doctor (see Warnings)
? [add NDA approved direction]
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Other
information
? [storage conditions]
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Inactive ingredients [list
ingredients in alphabetical order]
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Questions or comments? call
1-800-XXX-XXXX: [insert appropriate times when the
phone will be answered by a person, e.g., weekdays
8AM to 11 PM EST; weekends 9AM to 11 PM, EST]
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