PENZAL Q- acetaminophen, ethenzamide, caffeine anhydrous tablet 
OASIS TRADING

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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Acetaminophen, Caffeine Anhydrous, Ethenzamide

relief of: Headaches, Aches, Pain and Fever

Keep out of reach of children

■ adult and children 15 years of age and older: 1 capsules three times a day
■ children 11 to under 15 years of age: 1/2-2/3 capsules three times a day
■ children 8 to under 11 years of age: 1/2 capsules three times a day
■ children under 8 years of age: ask a doctor

Keep out of the reach of children. This package contains enough drug to seriously harm a child. Do not use with other drugs containing acetaminophen.
Use the smallest effective dose. Do not take more than the maximum daily dose. Overdose may result in severe or possibly fatal liver damage.
Do not take if allergic to acetaminophen. Consult a doctor if: your symptoms last for more than 5 days or fever lasts more than 3 days or you develop allergic reactions such as wheezing, rash or itching.
Ask a doctor or pharmacist before use if you: Are pregnant or breastfeeding, have chronic alcoholism; have a serious liver or kidney disease; use any other medications including natural health products, prescription drugs, salicylates or other pain and fever relief medications.
In case of overdose, call a Poison Control Centre or doctor immediately, even if you do not notice any possible signs or symptoms such as increased sweating, nausea, vomiting, stomach pain, and loss of appetite.

WARNING: Do not use if carton is open or if printed bottle neck band or inner foil seal is broken.

Store at room temperature, 15–30°C (59–86°F).

cellulose, corn starch, magnesium stearate, sodium starch glycolate

For oral use only

1

PENZAL Q 
acetaminophen, ethenzamide, caffeine anhydrous tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0034
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ETHENZAMIDE (UNII: L929ZCK4BF) (ETHENZAMIDE - UNII:L929ZCK4BF) ETHENZAMIDE200 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN300 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE50 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColoryellowScore2 pieces
ShapeOVALSize17mm
FlavorImprint Code PenzalQ
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72689-0034-110 in 1 BLISTER PACK; Type 0: Not a Combination Product11/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/20/2018
Labeler - OASIS TRADING (689991468)
Registrant - OASIS TRADING (689991468)
Establishment
NameAddressID/FEIBusiness Operations
OASIS TRADING689991468manufacture(72689-0034)

Revised: 3/2019
Document Id: 84581a0a-ea5d-0fae-e053-2a91aa0a6b83
Set id: 84581b9a-a878-afcb-e053-2a91aa0acd10
Version: 1
Effective Time: 20190318
 
OASIS TRADING