SANATOS LOZENGES- menthol lozenge
Pharmadel LLC

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.

----------

Sanatos Sore Throat Lozenges Honey-Lemon

Drug Facts

Active ingredient & Purposes

Active ingredients (in each lozenge)	Purposes
Menthol 5.5 mg................................................	Cough suppressant / oral anesthetic

Uses

For the temporary relief of

minor irritation and sore throats
cough as may occur with a cold

Warnings

Sore throat warning: if sore throat is severe persists for more than 2 days, is accompanied or followed by high fever, headache, rash, nausea or vomiting, consult a doctor promptly. These may be serious.

Ask a doctor before use if you have

persistent or chronic cough such as occurs with smoking, asthma or emphysema
a cough that is accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

a cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

Keep out of the reach of children.

Directions

adult and children 3 to under 12 years of age: allow the lozenge to dissolve one (1) drop slowly in mouth
repeat every 2 hours as needed or as directed by doctor
children under 3 years of age: consult a doctor

Other information

store in cool dry place below 77º F
protect from heat and light
do not use if package is torn or broken

Inactive ingredients

ascorbic acid, citric acid monohydrate, cordia dichotoma fruit, corn syrup, eucalyptus oil, hyssopus ofﬁcinalis ﬂowering top, greater galangal, justicia adhatoda leaf, licorice, long pepper, natural honey ﬂavor, natural lemon ﬂavor, sucrose.

Questions & comments?

1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Principal Display Panel

SanaTos®

Sore Throat Lozenges/Pastillas para el dolor de garganta

Relieves Cough/Alivia la Tos

Soothes Sore Throats/Calma Dolor de Garganta

Honey Lemon Flavor/Sabor Miel y Limón

5 pouches x 25 Lozenges each/5 bolsas x 25 pastillas cada una

Sanatos Cough Drop Honey Lemon

SANATOS LOZENGES
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55758-301
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.5 mg

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EUCALYPTUS OIL (UNII: 2R04ONI662)
JUSTICIA ADHATODA LEAF (UNII: HH159XOV81)
HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CORN SYRUP (UNII: 9G5L16BK6N)
GREATER GALANGAL (UNII: 7Y64R856MB)
SUCROSE (UNII: C151H8M554)
LONG PEPPER (UNII: 2NMG4EA7B1)
CORDIA DICHOTOMA FRUIT (UNII: R4RI8646ZR)
LICORICE (UNII: 61ZBX54883)
HONEY (UNII: Y9H1V576FH)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	17mm
Flavor	LEMON, HONEY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55758-301-05	5 in 1 CARTON	03/28/2019	09/29/2021
1	NDC:55758-301-25	1 in 1 BAG; Type 0: Not a Combination Product
2	NDC:55758-301-25	1 in 1 BAG; Type 0: Not a Combination Product	03/28/2019	09/29/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/28/2019	09/29/2021

Labeler - Pharmadel LLC (030129680)

Revised: 9/2021

Document Id: cd2a9781-a23a-40a5-e053-2995a90ae400

Set id: 852edba5-ed44-6212-e053-2a91aa0a9e44

Version: 3

Effective Time: 20210929

Pharmadel LLC