Dr Manzanilla Infant by Key Therapeutics Dr Manzanilla Infant

Dr Manzanilla Infant by

Drug Labeling and Warnings

Dr Manzanilla Infant by is a Otc medication manufactured, distributed, or labeled by Key Therapeutics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DR MANZANILLA INFANT- triprolidine hydrochloride syrup 
Key Therapeutics

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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Dr Manzanilla Infant

Dr. Manzanilla Infant

Key Therapeutics, 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.

Dr. Manzanilla Pediatric Syrup

Drug Facts

Active ingredients (in each 1 mL teaspoonful)

Purpose

Triprolidine HCl……….0.938 mg…………Antihistamine

Inactive Ingredients:

Sodium Benzoate, Purified Water, Sucralose, Hydroxypropyl Cellulose, Sorbitol, Bubblegum

Flavor.

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

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

Warnings:

Do not exceed recommended dosage.

Ask a doctor before use if the child has

• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor before use if the child is taking sedatives or tranquilizers.

When using this product

• excitability may occur, especially in children may cause drowsiness
  
• alcohol, sedatives and tranquilizers may increase the drowsiness effect

Stop use and ask a doctor if new symptoms occur.

KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

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

Do not exceed recommended dosage.

Directions:

• AGE: DOSE
• Children 4 to under 6 years of age: 1 dropperful (1.0 mL) every 4 to 6 hours not to exceed 4 doses (4.0 mL) in 24 hours.
• Children 2 to under 4 years of age: 2/3 dropperful (0.67 mL) every 4 to 6 hours, not to exceed 4 doses (2.67 mL) in 24 hours.
• Infants 4 months to under 2 years age: 1/3 dropperful (0.33 mL) every 4 to 6 hours, not to exceed 4 doses (1.33 mL) in 24 hours.

Other Information

Store at 15°-30 ° C (59 °-86 ° F).

Supplied in a tight, light-resistant container with a child-resistant cap.

Questions? Comments?

Call 1-888-981-8337

Manufactured for:

Key Therapeutics, LLC

Flowood, MS 39232

PRINCIPAL DISPLAY PANEL

NDC: 70868-701-30
Dr. Manzanilla
Infant
Antihistamine
Bubble Gum Flavor
1 fl oz (30 mL)

DR MANZANILLA INFANT 
triprolidine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70868-701
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	0.938 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70868-701-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/11/2019	03/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/11/2019	03/31/2020

Labeler - Key Therapeutics (080318791)

Revised: 4/2020

Document Id: 983d5ba4-d9aa-43a8-a9f5-64a2f2ae05ff

34390-5

Set id: 3fb0eac7-73dd-400f-b463-ce7abdcf3c3d

Version: 2

Effective Time: 20200407

 

Key Therapeutics