PENZAL Q- acetaminophen, ethenzamide, caffeine anhydrous tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ETHENZAMIDE (UNII: L929ZCK4BF) (ETHENZAMIDE - UNII:L929ZCK4BF), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Available from:
OASIS TRADING
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
relief of: Headaches, Aches, Pain and Fever ■ 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
Authorization status:
OTC monograph not final
Authorization number:
72689-0034-1

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

PENZAL Q

acetaminophen, ethenzamide, caffeine anhydrous tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:726 8 9 -0 0 34

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

OASIS TRADING

ETHENZAMIDE (UNII: L9 29 ZCK4BF) (ETHENZAMIDE - UNII:L9 29 ZCK4BF)

ETHENZAMIDE

20 0 mg

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

30 0 mg

CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E)

CAFFEINE

50 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B)

PO WDERED CELLULO SE (UNII: SMD1X3XO9 M)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

STARCH, CO RN (UNII: O8 232NY3SJ)

Product Characteristics

Color

ye llo w

S core

2 pieces

S hap e

OVAL

S iz e

17mm

Flavor

Imprint Code

Pe nz a lQ

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:726 8 9 -0 0 34-1 10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

11/20 /20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

11/20 /20 18

Labeler -

OASIS T RADING (689991468)

Registrant -

OASIS T RADING (689991468)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

OASIS TRADING

6 8 9 9 9 146 8

ma nufa c ture (726 8 9 -0 0 34)

Revised: 3/2019

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