SED-MAX- acetaminophen 500 mg with caffeine 65mg tablet, coated 
Command Brands, LLC

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029 - SED-MAX

Active ingredient(s)

Acetaminophen 500mg

Caffeine 65mg

Purpose

Pain reliever/fever reducer

Pain reliever aid

Uses

temporary relief of 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 8 caplets in 24 hours, which is the maximum daily amount

■ taken with other drugs containing acetaminophen

■ adult has 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 heart beat.

Do not use

■ if you are allergic to acetaminophen

■ with other products 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

■ any new symptoms occur

■ painful area is red or swollen

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

These could be signs of a serious skin condition 

Pregnancy/Breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

Adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 8 caplets in 24 hours

Children under 12 years of age: ask a doctor

Other information

■ store at 20-25C (68-77F)

■ do not use if imprinted safety seal under cap is broken or missing

■you may report side effects to 1-888-952-0050

Inactive ingredients

corn starch, croscarmellose, crospovidone, D&C red #27 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Principal Display Panel

Sedmax

Sedmax

 

SED-MAX 
acetaminophen 500 mg with caffeine 65mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69197-029
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE (UNII: 029TFK992N)  
CROSPOVIDONE (UNII: 2S7830E561)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code AZ;029
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69197-029-201 in 1 CARTON11/26/2014
120 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01311/26/2014
Labeler - Command Brands, LLC (060684113)

Revised: 1/2017
Document Id: bd14fe1d-1a3f-4854-aab9-dbcd09046365
Set id: 4920a0e9-6f88-4df0-8657-77c95a3b9617
Version: 4
Effective Time: 20170119
 
Command Brands, LLC