Label: ALLERGY RELIEF- diphenhydramine hcl liquid
- NDC Code(s): 52083-665-16
- Packager: KRAMER NOVIS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated March 3, 2020
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- Drug Facts
- Active Ingredient (in each 5 mL tsp)
Do not use
• with any other product containing diphenhydramine, even one used on skin
• to make a child sleepy
Ask a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to the enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
When using this product:
• excitability might occur, especially in children
• marked drowsiness may occur • avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness effect
• be careful when driving a motor vehicle or operating machinery
If pregnant or breast-feeding, ask a health professional before use.
• Take every 4 to 6 hours, or as directed by doctor.
• Do not exceed recommended dose.
Adults and Children 12 years of age and over: take 10 to 20 mL (2 to 4 tsp) not to exceed 300 mg in 24 hours Children 6 to under 12 years of age: take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours Children under 6 years of age: consult a doctor
- Other information
- Inactive ingredients
- Questions or comments?
SPL UNCLASSIFIED SECTION
Compare to the active ingredient of Benadryl® Allergy Liquid*
√ Runny Nose
√ Itchy, Watery Eyes
√ Itchy Throat
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy.
TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS TORN, BROKEN OR MISSING.
INGREDIENTS AND APPEARANCE
diphenhydramine hcl liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-665 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-665-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/02/2020 Labeler - KRAMER NOVIS (090158395)