AP-Hist DM description, usages, side effects, indications, overdosage, supplying and lots more!

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AP-Hist DM

Allegis Pharmaceuticals, LLC

AP-Hist DM Liquid


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each 5 mL teaspoonful) Purpose
Brompheniramine Maleate 4 mg Antihistamine
Dextromethorphan HBr 15 mg Antitussive
Phenylephrine HCl 7.5 mg Nasal Decongestant

AP-Hist DM Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product

  • 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

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a persistent or chronic cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask doctor if

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
  • new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage

Adults and children 12 years of age and over: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours
Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours
Children under 6 years of age: Consult a physician

AP-Hist DM Other information

Store at 59° - 86° F (15° - 30° C) [see USP for Controlled Room Temperature].

Inactive ingredients

Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Strawberry Flavor.

Question? Comments?

Call (601) 859-0038

Distributed by: Allegis Pharmaceuticals, 276 Nissan Parkway F100 Canton, MS 39046

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 28595-800-16

AP-HIST DM
Liquid

Antihistamine • Antitussive
• Nasal Decongestant

Sugar Free • Alcohol Free • Dye Free

Each teaspoonful (5 mL) for oral
administration contains:
Brompheniramine Maleate
4 mg
Dextromethorphan HBr
15 mg
Phenylephrine HCl
7.5 mg

Strawberry Flavor

Distributed by:

ALLEGIS PHARMACEUTICALS

276 Nissan Parkway F100
Canton, MS 39046

16 fl oz (473 mL)

AP-Hist DM

AP-Hist DM

Brompheniramine Maleate, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:28595-800
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Brompheniramine Maleate BROMPHENIRAMINE 4 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 7.5 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
propylene glycol
water
SODIUM CITRATE
saccharin sodium
sorbitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:28595-800-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-04-15


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Be sure to consult your doctor before taking any medication!
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