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Drug Facts
Star Drops
FDA Label NDC 81238-5825
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Western First Aid Safety Dba Aramark for the product Star Drops (NDC 81238-5825). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredient (in each drop)
Menthol 5.8 mg
Otc - Purpose
Purpose
Cough Suppressant/Oral Anesthetic
Indications & Usage
Uses:
Temporarily Relieves:
■ Cough as may occur with a cold Occasional
minor irritation and sore throat
Warnings
Warnings:
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. These
symptoms may be serious. If sore mouth
symptoms do not improve in 7 days, see your
dentist or doctor promptly. These symptoms
may be serious.
Otc - Ask Doctor
Ask a doctor before use if you have:
■ Persistent cough or chronic cough such as
occurs with smoking, asthma, or emphysema
■ Cough accompanied by excessive phlegm
(mucus)
Otc - When Using
When using this product:
■ Do not exceed recommended dosage
Otc - Stop Use
Stop use and consult doctor if:
■ 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.
■Sore throat is severe, or irritation, pan or
redness lasts. These could be signs of a
serious condition.
■ Sore mouth does not improve in 7 days.
Pregnancy
If pregnant or breast-feeding, ask a health
professional before use.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children. In case
of accidental overdose, get medical help or
contact a Poison Control Center right away
Dosage & Administration
Directions
| Adults and children: (5 years and older) | Allow 1 drop to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor. |
| Children under 5 years: | Ask a doctor. |
Other Safety Information
Other information 10-calories per drop
Tamper Evident: Do not use if bag/pouch is
torn or open.
Inactive Ingredient
Inactive ingredients:
Corn Starch, corn syrup, eucalyptus oil,
FD&C red no. 40, glycerin, medium chain
triglycerides, natural & artificial flavors,
soybean oil, sucrose and water.
Package Label
aramark
Cherry Cough Drops
Menthol / Mentol 5.8mg
Cough Suppressant &
Anesthetic with Vapor Action
Individually Wrapped Cough Drops
50 TABLETS Part # 582R23
PER BOX
Compare active ingredient to:
HALLS®
Registered Trademark of Warner-Lambert
MANUFACTURED FOR:
Aramark
Lenexa, KS 66219
(913) 269-9611
Retain carton for complete product information
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