Thirty Madison Inc Antihistamine Drug Facts

picnic antihistamine by

Drug Labeling and Warnings

picnic antihistamine by is a Otc medication manufactured, distributed, or labeled by 30M One, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PICNIC ANTIHISTAMINE- fexofenadine hydrochloride tablet, film coated 
30M One, Inc.

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Thirty Madison Inc Antihistamine Drug Facts

Active ingredient (in each tablet)

Fexofenadine HCl 180 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• itchy, watery eyes
• sneezing
• itching of the nose or throat

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

kidney disease. Your doctor should determine if you need a different dose.

When using this product

• do not take more than directed
• do not take at the same time as aluminum or magnesium antacids
• do not take with fruit juices (see Directions)

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

• adults and children 12 years of age and over:

  take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours

• children under 12 years of age:

  do not use

• adults 65 years of age and older:

  ask a doctor

• consumers with kidney disease:

  ask a doctor

Other information

• do not use if printed foil under cap is broken or missing
• store between 20° -25°C (68° -77°F)
• protect from excessive moisture
• this product meets the requirements of USP Dissolution Test 2

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

ALLERGY

picnic

FEXOFENADINE HYDROCHLORIDE TABLETS 180 mg

Antihistamine

Compare to the active ingredient in Allegra® Allergy / Non-Drowsy / 24 HR / Indoor / Outdoor

Allergy Relief of: Sneezing; Runny Nose; Itchy, Watery Eyes & Itchy Nose or Throat

Actual Size

90 TABLETS

PICNIC ANTIHISTAMINE 
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80159-112
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	L847
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80159-112-03	1 in 1 CAPSULE	04/25/2022	12/31/2023
1		90 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 80159-112-01	1 in 1 CARTON	04/24/2022	04/01/2024
2		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA212971	04/24/2022	04/01/2024

Labeler - 30M One, Inc. (117621005)

Revised: 12/2024

Document Id: 95e48bf9-5a75-4575-b7de-35afb90a85e2

34390-5

Set id: 6f8209d9-f5fa-4732-a007-f2290351a7a0

Version: 2

Effective Time: 20241205