FDA.reportPublic FDA data

PinAway

Manufacturer
Denison Pharmaceuticals, Inc.
Effective date
2017-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:00:40

Label at a glance#

ProductPinAway
Active ingredientPYRANTEL PAMOATE
Label structure13 sections

Dosage and administration

shake well before using important - treat the entire household take only one dose unless directed by a doctor Under 25 lbs or under age 2, consult a doctor 25-37 lbs.......1/2 tsp 38-62 lbs.......1 tsp 63-87 lbs.......1 1 / 2 tsp 88-112 lbs.....2 tsps 113-137 lbs...2 1 / 2 tsps 138-162 lbs...3 tsps 163-187 lbs...3 1 / 2 tsps over187 lbs....4 tsps

Storage and handling

store at 15°- 30°C (59°- 86°F)

Label contents#

Full prescribing information#

Active ingredient (in each 1 mL)

OTC - ACTIVE INGREDIENT SECTION

Pyrantel pamoate 144 mg

(equivalent to 50 mg pyrantel base)

Purpose

OTC - PURPOSE SECTION

Pinworm treatment

Use

INDICATIONS & USAGE SECTION

for the treatment of pinworms.

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • you're pregnant
  • have liver disease

OTC - WHEN USING SECTION

When using this product abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. If any of these symptoms persist, consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • important - treat the entire household
  • take only one dose unless directed by a doctor

Under 25 lbs or under age 2, consult a doctor

25-37 lbs.......1/2 tsp

38-62 lbs.......1 tsp

63-87 lbs.......1 1/ 2 tsp

88-112 lbs.....2 tsps

113-137 lbs...2 1/ 2 tsps

138-162 lbs...3 tsps

163-187 lbs...3 1/ 2 tsps

over187 lbs....4 tsps

Other information

OTHER SAFETY INFORMATION

  • read package insert carefully before using
  • if signs of pinworm persist, see a doctor

STORAGE AND HANDLING SECTION

  • store at 15°- 30°C (59°- 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, citric acid, flavor, methylparaben, microcrystalline cellulose, polysorbate 80, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sorbitol solution

SPL UNCLASSIFIED SECTION

Distributed by:

Cara Incorporated

333 Strawberry Field Road

Warwick, RI 02886

www.caraincorporated.com

Made in U.S.A. with foreign and domestic ingredients.

Cara PinAway

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70309-080-02

PYRANTEL PAMOATE

(PYRANTEL BASE 50 mg / mL)

PINWORM TREATMENT

Treats Ages 2 to Adult

  • Full prescription strength
  • Single dose effectiveness
  • Sugar-free caramel-flavored liquid
  • Measuring cup included

2 FL OZ (60 mL)

Cara Pin awayCara Pin away

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0295-10620295-1062-13

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
METHYLPARABENA2I8C7HI9TIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
PYRANTEL PAMOATE81BK194Z5MACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
07936551-9fcc-4eff-ab56-b52a1e5703bbe10400a6-234d-4ab5-8d46-627a515bc0922017-01-01WarningsExact identifier
spl id: 07936551-9fcc-4eff-ab56-b52a1e5703bb
spl set id: e10400a6-234d-4ab5-8d46-627a515bc092

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.