Label: DIPHENHYDRAMINE HYDROCHLORIDE solution
- NDC Code(s): 83720-502-04, 83720-502-16
- Packager: Oncor Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 27, 2025
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENTActive ingredients (in each 5 mL teaspoonful) Purpose - Diphenhydramine Hydrochloride 12.5mg .............................Antihistamine
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Uses
- sneezing - - runny nose - - itchy, watery eyes - - itching of the nose or throat - - temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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Warnings
Do not use - - to make a child sleepy - - with any other product containing diphenhydramine, even one used on skin
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Ask a doctor before use if you have
- glaucoma - - trouble urinating due to an enlarged prostate gland - - a breathing problem such as emphysema or chronic bronchitis
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Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers.
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When using this product
- marked drowsiness may occur - - avoid alcoholic drinks - - alcohol, sedatives, and tranquilizers may increase drowsiness - - be careful when driving a motor vehicle or operating machinery - ...
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If pregnant or breast-feeding,
ask a health professional before use.
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Directions
- take every 4 to 6 hours or as directed by a doctor - - do not take more then directed - - mL=milliliter - - find right dose on chart below - Children under 2 years Do not use - Children 2 to 5 ...
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Inactive ingredients
citric acid, flavor, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose.
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Other information
- each 1 tsp (5mL) contains: sodium 4 mg - - store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]. Protect from freezing. - tamper evident by foil seal under cap. Do not use if foil ...
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KEEP OUT OF REACH OF CHILDRENKeep out of reach of children.
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OVERDOSAGEIn case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
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Questions?
You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.
- SPL UNCLASSIFIED SECTION
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Principal Display Panel
Oncor Pharmaceuticals - NDC 83720-502-16 - Diphenhydramine Hydrochloride - Oral Solution - 12.5 mg/5 ml - Antihistamine - Cherry Flavor - RELIEVES - - Sneezing - - Itchy, Watery Eyes - - Runny Nose - ...
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PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCEProduct Information