SEDALMEX FORTE- acetaminophen, aspirin, caffeine tablet

SEDALMEX FORTE by

Drug Labeling and Warnings

SEDALMEX FORTE by is a Otc medication manufactured, distributed, or labeled by Belmora LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each tablet)

Acetaminophen        250 mg
Aspirin (NSAID*)   250 mg
Caffeine                   65 mg
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer
Pain reliever/fever reducer
Pain reliever aid

Uses

temporarily relieves minor aches and pains due to:

headache  muscular aches    arthritis pain

a cold        toothache            premenstrual and menstrual cramps

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: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash
If a skin reaction occurs, stop use and seek medical help right away.

Allergy alert: Aspirin (NSAIDs) may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock

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

Stomach bleeding warning: This product contains an NSAID, 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 blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
take more or for a longer time than directed 
have 3 or more alcoholic drinks every day while using this product 

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 heart beat.

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 ever have had an allergic reaction to acetaminophen, aspirin or any other pain relievers/fever reducers

Ask a doctor before use if
stomach bleeding warning applies to you
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease 
you are taking a diuretic  you have a history of stomach problems, such as heartburn
you have asthma  you have liver disease

Ask a doctor or pharmacist before use if you are

if you are taking prescription drug for gout, diabetes, or arthritis
taking any other drug, or under a doctor’s care for any serious condition

Stop use and ask a doctor if
an allergic reaction occurs. Seek medical help right away.
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

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• ringing in the ears or loss of hearing occurs
• painful area is red or swollen 
• any new symptoms occur

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use aspirin at 20 weeks or later in 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not use more than directed
 drink a full glass of water with each dose

• Adults and children: (12 years and older): Take 2 Tablets every 6 hours as needed; not more than 8 tablets in 24 hours
• Children under 12 years: Ask a doctor

Other information

read all product information before using. Keep box for important information.

store at room temperature between 68°-77°F (20°-25°C)

avoid excessive heat and humidity 

tamper evident sealed packets

do not use any opened or torn packets

each tablet contains: Magnesium 0.58 mg 

Inactive ingredients

colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyvinyl pyrrolidone, polyethylene glycol, pregelatinized starch, starch 1500, stearic acid, talc

Questions or comments?

1-888-779-2877 M-F 9AM-5PM EST

SPL UNCLASSIFIED SECTION

Fast Headache Relief!

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

Distributed by 

Belmora LLC, 3033 Wilson BLvd.,

Suite 700. Arlington, VA 22201,                                                              

MADE IN INDIA

Packaging

INGREDIENTS AND APPEARANCE

SEDALMEX FORTE 
acetaminophen, aspirin, caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27854-303
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE K30 (UNII: U725QWY32X)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	white (WHITE TO OFF WHITE WITH SPECKS)	Score	no score
Shape	capsule (CAPSULE SHAPED BICONVEX)	Size	18mm
Flavor		Imprint Code	S53
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27854-303-01	40 in 1 BOX	06/01/2024
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	06/01/2024

Labeler - Belmora LLC (112753244)