EXTRA STRENGHTH ACETAMINOPHEN- acetaminophen tablet 
OPMX LLC

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Temp X Caplets

Active Ingredient

(in each tablet)

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Uses

Temporary relieves minor aches and pains due to:

Warnings

Liver warning:This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3000 mg) in 24 hours. Severe liver damage may occur if you take

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs; stop use and seek medical help right away.

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

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 reccomended dose (overdose) may cause liver damage. 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

Adults and children 12 years of age and older:

Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Other Information

Inactive Ingredients

Colloidal silicon dioxide, pregelatinized starch, povidone (pvp k-30), croscarmellose sodium, potassium sorbate, stearic acid

Questions or Comments

Call 619-600-5632 Monday through Friday 9AM-5PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tempxb

Tempxa

EXTRA STRENGHTH ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-107
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code AP500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-107-401 in 1 CARTON07/31/2017
140 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01307/31/2017
Labeler - OPMX LLC (029918743)
Establishment
NameAddressID/FEIBusiness Operations
Health Pharma USA LLC080804485manufacture(69729-107)

Revised: 12/2023
Document Id: 0c91fa8f-dc41-e004-e063-6294a90a6c3e
Set id: ae6dae28-6f4f-16d1-e053-2995a90adbab
Version: 4
Effective Time: 20231215
 
OPMX LLC