TENSION HEADACHE RELIEF- acetaminophen, caffeine tablet, film coated

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

MAH:

Harmon Store Inc.

INN:

ACETAMINOPHEN

composition:

ACETAMINOPHEN 500 mg

administration_route:

ORAL

prescription_type:

OTC DRUG

therapeutic_indication:

Pain reliever  - temporarily relieves minor aches and pains due to: headache  muscular aches - headache  - muscular aches

authorization_status:

OTC monograph not final

SPC

TENSION HEADACHE RELIEF- ACETAMINOPHEN, CAFFEINE TABLET, FILM COATED
HARMON STORE INC.
_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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CORE VALUES 44-428-DELISTED
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
Acetaminophen 500 mg
(formulated with 65 mg caffeine)
_PURPOSE_
Pain reliever
_USES_
temporarily relieves minor aches and pains due to:
headache
muscular aches
_WARNINGS_
LIVER WARNING: This product contains acetaminophen. The maximum daily
dose of this
product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may
occur if you take:
more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms
may
include:
blisters
rash
skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
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
heartbeat.
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.
if you are allergic to acetaminophen
ASK A DOCTOR BEFORE USE IF YOU HAVE
liver disease.
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking the blood thinning drug warfarin.
STOP USE AND ASK A DOCTOR IF
new symptoms occur
painful area is red or swollen
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 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.
In cas