Kids Cold and Cough Nighttime Grape Flavor

Kids Cold and Cough Nighttime Grape Flavor is an FDA-registered drug product whose active ingredient is ONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFUR. It is labelled by Hyland's Consumer Health Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 54973-4111, label effective 20220817. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFUR are most often described in connection with: helps temporarily, relieve symptoms, common cold, children night, including cough, runny nose, post nasal, drip sneezing. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses ■ Helps temporarily relieve symptoms of common cold in children at night, including: ■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ sore throat ■ nasal or chest congestion ■ occasional sleeplessness

Directions ■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing cup provided. ■ Do not use dosing cup with other products. ■ On dosing cup, mL = milliliter. Children 4 years to under 6 years 5 mL at bedtime and every 4 hours during the night until relieved. Children 6 years to under 12 years 10 mL at bedtime and every 4 hours during the night until relieved. Adults and children 12 years and over 15 mL at bedtime and every 4 hours during the night until relieved.

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. Ask a doctor before use if you have ■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus). Stop use and ask a doctor if ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache. If pregnant or breastfeeding Ask a health professional before use. Keep out of reach of children

What is Kids Cold and Cough Nighttime Grape Flavor used for?
Uses ■ Helps temporarily relieve symptoms of common cold in children at night, including: ■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ sore throat ■ nasal or chest congestion ■ occasional sleeplessness

Who makes Kids Cold and Cough Nighttime Grape Flavor?
Hyland's Consumer Health Inc. is the labeler of record for Kids Cold and Cough Nighttime Grape Flavor.

What form does Kids Cold and Cough Nighttime Grape Flavor come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Kids Cold and Cough Nighttime Grape Flavor prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Kids Cold and Cough Nighttime Grape Flavor been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.