Label: HEALTH MART CHILDRENS ALLERGY PLUS CONGESTION- diphenhydramine hcl, phenylephrine hcl solution
- NDC Code(s): 62011-0257-1
- Packager: Strategic Sourcing Services LLC
- 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.
Drug Label Information
Updated January 29, 2020
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- Official Label (Printer Friendly)
- Active ingredients (in each 5 mL)
- Purpose
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Uses
- •
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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- runny nose
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- sneezing
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- itchy, watery eyes
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- itching of the nose or throat
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- nasal congestion
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- stuffy nose
- •
- temporarily relieves these symptoms due to the common cold:
- •
- runny nose
- •
- sneezing
- •
- nasal congestion
- •
- stuffy nose
- •
- temporarily relieves sinus congestion and pressure
- Warnings
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Do not use
- •
- to make a child sleepy
- •
- with any other product containing diphenhydramine, even one used on skin
- •
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
-
Directions
- •
- find right dose on chart below
- •
- mL = milliliter
- •
- take every 4 hours
- •
- do not take more than 6 doses in 24 hours
Age (yr)
Dose (mL)
children under 4 years
do not use
children 4 to 5 years
do not use unless
directed by a doctor
children 6 to 11 years
5 mL
adults and children 12 years and over
10 mL
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
- Other information
- Inactive ingredients
- Questions or comments?
-
Package/Label Principal Display Panel
Compare to Children’s Benadryl® Allergy Plus Congestion active ingredients
ORAL SOLUTION
Children’s Allergy Plus Congestion
Antihistamine (Diphenhydramine HCl)
Nasal Decongestant (Phenylephrine HCl)
Relieves:
Runny Nose; Sneezing
Itchy, Watery Eyes; Itchy Throat or Nose
Sinus Congestion; Stuffy Nose
4 Hours/Dose • Sugar Free
Gluten Free • Alcohol Free
GRAPE FLAVOR
4 Fl oz (118 mL)
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INGREDIENTS AND APPEARANCE
HEALTH MART CHILDRENS ALLERGY PLUS CONGESTION
diphenhydramine hcl, phenylephrine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0257 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) Product Characteristics Color PURPLE (clear) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62011-0257-1 1 in 1 CARTON 02/12/2018 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/12/2018 Labeler - Strategic Sourcing Services LLC (116956644)