CEPACOL SENSATIONS  HYDRA- benzocaine lozenge 
Reckitt Benckiser LLC
Reference Label Set Id: 756613d7-ed0e-4be9-8939-6e752eef39a3

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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Cepacol® Sensations™ Hydra

Drug Facts

Active ingredient (in each lozenge)

Benzocaine 3 mg

Purpose

Oral pain reliever

Uses

temporary relief of occasional

  • sore throat
  • sore mouth
  • minor mouth irritation
  • pain associated with canker sores

Warnings

Allergy alert

  • Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other 'caine' anesthetics.

Sore throat warning

  • If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly.

Do not use in a child under 5 years of age.

Stop use and ask a doctor or dentist if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

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

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

Do not exceed recommended dosage.

Directions

  • adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
  • children under 5 years of age: do not use

Other information

  • store at room temperature 20-25°C (68-77°F)
  • protect contents from humidity

Inactive ingredients

D&C yellow #10, FD&C blue #1, flavors, glucose, purified water, sodium bicarbonate, sorbitol, sucralose, sucrose

Questions?

Call 1-888-963-3382 You may also report side effects to this phone number.

Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 4 Lozenge Carton

NDC 63824-762-04

new!

Cēpacol®
Sensations™

Hydra

Benzocaine 3 mg – Oral Pain Reliever

▶ Relieves Sore Throat Pain
▶ Instant Refreshing Comfort

4 Lozenges
citrus splash

Principal Display Panel - 4 Lozenge Carton
CEPACOL SENSATIONS   HYDRA
benzocaine lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-762
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine3 mg
Inactive Ingredients
Ingredient NameStrength
D&C yellow No. 10 (UNII: 35SW5USQ3G)  
FD&C blue No. 1 (UNII: H3R47K3TBD)  
dextrose (UNII: IY9XDZ35W2)  
water (UNII: 059QF0KO0R)  
sodium bicarbonate (UNII: 8MDF5V39QO)  
sorbitol (UNII: 506T60A25R)  
sucralose (UNII: 96K6UQ3ZD4)  
sucrose (UNII: C151H8M554)  
Product Characteristics
ColorGREENScoreno score
ShapeROUNDSize18mm
FlavorImprint Code S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-762-041 in 1 CARTON
14 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63824-762-941 in 1 CARTON
24 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:63824-762-202 in 1 CARTON
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35605/28/201206/30/2016
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 1/2016
Document Id: 8f492b9f-fe8e-446b-9227-aac5457e2279
Set id: 62cf55ca-8bf7-4974-91a1-76e57556b202
Version: 3
Effective Time: 20160108
 
Reckitt Benckiser LLC