SEDALMEX- acetaminophen, caffeine tablet

SEDALMEX by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients (in each gelcap)

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. 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:

• skin reddening
• blisters
• rash

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

• if you are allergic to acetaminophen
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  

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 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 case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. 

Directions

• do not use more than directed
• adults and children 12 years and over: take 2 gelcaps every 6 hours. Do not take more than 6 gelcaps in 24 hours.
• children under 12 years: ask a doctor
  

Other information

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• avoid high humidity
• see end flap for expiration date and lot number
  

Inactive ingredients

corn starch, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac glaze, simethicone, silicon dioxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

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

Principal display panel

SEDALMEX

NDC: 27854-301-01

Acetaminophen &
Caffeine Pain Reliever

24 GELCAPS

ACETAMINOPHEN 500 mg, CAFFEINE 65 mg

RAPID RELEASE
ASPIRIN FREE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by Belmora LLC
2231 Crystal Dr., Suite 1000
Arlington, VA 22202
www.sedalmexusa.com

 

Sedalmex 44-572

INGREDIENTS AND APPEARANCE

SEDALMEX 
acetaminophen, caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27854-301
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	L;2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27854-301-01	1 in 1 CARTON	08/08/2019
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	08/08/2019

Labeler - Belmora LLC (112753244)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(27854-301)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(27854-301)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(27854-301)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(27854-301)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(27854-301)