BF-PARADAC- acetaminophen tablet

BF-PARADAC by

Drug Labeling and Warnings

BF-PARADAC by is a Otc medication manufactured, distributed, or labeled by Bright Future Pharmaceutical Laboratories Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Acetaminophen 500mg

Purpose

Pain Reliever - Reduce Fever

Uses

For temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular ache, to reduce fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
More than 6tablets in 24 hours, which is the maximum daily amount
With other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cayse severe skin reactions. Symptoms may include
Skin reddening
Blisters
Rash
If skin reaction occurs, stop use and seek medical help right away

Do not use

With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
For more than 10 days for pain unless directed by a doctor
For more than 3 days for fever unless directed by a doctor

Ask doctor before use if you have

Liver disease

Ask doctor or pharmacist before use if

You are taking the blood thinning drug warfarin

Stop using and ask a doctor if

Symptoms do not improve
New symptoms occur
Pain or fever persists or gets worse

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Directions

Do not take more than directed (see overdose warning)
Adults and children 12 years and over:
Take 2 tablets every 6 hours while symptoms last
Swallow whole – do not crush, chew or dissolve
Do not take more than 6 tablets in 24 hours, unless directed by a doctor
Do not use for more than 10 days unless directed by a doctor
Children under 12 years
Ask a doctor

Other Information

* Don’t store above 25°C * Keep tightly closed.

Inactive Ingredients

Corn starch, Ethylparaben, Povidone, Propylparaben, Stearic acid, Pregelatinized starch, sodium starch glycollate

Questions or Comments?

(631)-227-3930 ext 129 M-F 9am to 5 pm PST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BF-PARADAC 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10884-2228
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)	31 mg
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)	11 mg
POVIDONE (UNII: FZ989GH94E)	10 mg
STEARIC ACID (UNII: 4ELV7Z65AP)	3 mg
ETHYLPARABEN (UNII: 14255EXE39)	0.3 mg
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.3 mg

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	13mm
Flavor		Imprint Code	B;F
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10884-2228-2	2 in 1 CARTON	09/19/2001
1		10 in 1 BLISTER PACK; 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	09/19/2001

Labeler - Bright Future Pharmaceutical Laboratories Limited (663118677)

Establishment
Name	Address	ID/FEI	Business Operations
Bright Future Pharmaceutical Laboratories Limited		663118677	manufacture(10884-2228)