CETAFEN- acetaminophen tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

A-S Medication Solutions

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Uses: Temporarily relieves minor aches and pains due to: - headache - muscular aches - backache - minor arthritis pain - the common cold - toothache - menstrual cramps Temporarily reduces fever Do not use with any other drug containing acetaminophen (prescription or non-prescription) Stop use and ask a doctor if: - new symptom occur - redness or swelling is present - fever worsens or lasts for more than 3 days - pain worsens or lasts for more than 10 days These could be signs of a serious condition

Product summary:

Product: 50090-3140 NDC: 50090-3140-0 2 TABLET in a PACKET / 500 in a BOX, UNIT-DOSE

Authorization status:

OTC monograph not final

Summary of Product characteristics

CETAFEN- ACETAMINOPHEN TABLET
A-S MEDICATION SOLUTIONS
_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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CETAFEN
Active Ingredient (in each tablet): Acetaminophen 325mg
Uses:
Temporarily relieves minor aches and pains due to:
headache
muscular aches
backache
minor arthritis pain
the common cold
toothache
menstrual cramps
Temporarily reduces fever
Warnings:
Liver warning: This product contains acetaminophen. Severe liver
damage may occur if you take:
more than 8 tablets 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
Do not use with any other drug containing acetaminophen (prescription
or non-prescription)
Ask a doctor or pharmacist before use if:
you are taking the blood thinning drug warfarin
you do not know if other drugs you are taking contain acetaminophen
Ask a doctor before use if you have liver disease
Stop use and ask a doctor if:
new symptom occur
redness or swelling is present
fever worsens or lasts for more than 3 days
pain worsens or lasts for more than 10 days
These could be signs of a serious condition
If pregnant or breast-feeding, ask a health professional before use
Keep out of reach of children
Overdose warning: Taking more than the recommended dose (overdose) may
cause liver damage. Quick
medical attention is critical for adults as well as for children even
if you do not notice any signs or
symptoms. In case of overdose, get medical help or contact Poison
Control Center right away. 1-800-
222-1222
Directions: Do not take more than directed
Adults and children 12 year of age and over:
take 2 tables every 4 to 6 hours while symptoms persist
do not take more than 8 tablets in 24 hours unless directed by a
doctor
Children under 12 years of age: do not use; this will provide more
than the recommended dose
(overdose) for children und