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Drx Choice childrens allergy chews drug information

DIPHENHYDRAMINE HCL
RARITAN PHARMACEUTICALS INC · ORAL

Product NDC: 68163-012

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameDIPHENHYDRAMINE HCL
Labeler / manufacturerRARITAN PHARMACEUTICALS INC
RouteORAL
Drug classDrug class not supplied in source label
Product NDC68163-012
Label effective date2026-09-05

Official product label reference

Drx Choice childrens allergy chews — RARITAN PHARMACEUTICALS INC

This page contains 14 source sections for DIPHENHYDRAMINE HCL, oral route. Label set dd2be906-bd0a-437c-9693-54b9391a5da3, version 5.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Uses ▪ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. ▪ runny nose ▪ itchy, watery eyes ▪ sneezing ▪ itching of the nose or throat

Purpose

Purpose Antihistamine
Dosage and administration — label text
Directions ▪ chew one tablet completely at the onset of symptoms. Do not swallow tablets whole. ▪ Find right dose on chart below ▪ take every 4 to 6 hours, or as directed by a doctor ▪ do not take more than 6 doses in 24 hours Age (Yr) Dose (chewable tablets) children under 2 years of age do not use children 2 to under 5 years of age do not use unless directed by a doctor children 6 to under 12 years of age 1 to 2 tablets adults and children 12 years of age and over 2 to 4 tablets Table text from source: | Age (Yr) | Dose (chewable tablets) | children under 2 years of age | do not use | children 2 to under 5 years of age | do not use unless directed by a doctor | children 6 to under 12 years of age | 1 to 2 tablets | adults and children 12 years of age and over | 2 to 4 tablets
Warnings
Warnings Do not use ▪ to make a child sleepy ▪ with any other product containing diphenhydramine, even one used on skin Ask your doctor before use if you have ▪ glaucoma ▪ a breathing problem such as emphysema or chronic bronchitis ▪ trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. 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 ▪ excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222
Active ingredient
Active ingredient (in each tablet) Diphenhydramine HCl 12.5 mg
Do not use
Do not use ▪ to make a child sleepy ▪ with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use
Ask your doctor before use if you have ▪ glaucoma ▪ a breathing problem such as emphysema or chronic bronchitis ▪ trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
While using this medicine
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 ▪ excitability may occur, especially in children
Pregnancy or breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Child safety
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222
Storage and handling
Other information ▪ store below at room temperature. Avoid high humidity. Protect from light.
Inactive ingredient
Inactive ingredients citric acid, crospovidone, D&C Red No.30, dextrose, FD&C Blue No 1, flavors, magnesium stearate, maltodextrin, potassium citrate, silica, sodium polystyrene sulfonate, starch, sucralose
Questions
Questions or comments ? 1-866-467-2748

Official sources and product identifiers

Substances listed: DIPHENHYDRAMINE HYDROCHLORIDE

RxNorm identifiers: 1049900

Package NDC codes

68163-012-48

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.