PLURATUSS - brompheniramine maleate, codeine phosphate, and phenylephrine hydrochloride liquid 
Creekwood Pharmaceutical, Inc.

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.

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Pluratuss

Drug Facts

Active ingredients                                 Purpose
(in each 5 mL teaspoonful)
Brompheniramine Maleate 4 mg..................... Antihistamine
Codeine Phosphate 10 mg................................ Antitussive
                                                          (cough suppressant)
Phenylephrine Hydrochloride 7.5 mg.............. Decongestant

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 the 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 physician or pharmacist before taking this product.

Ask a physician before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to the enlargement of the prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm
  • a chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

Ask a physician or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • may cause or aggravate constipation

Stop use and ask a physician 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
  • side effects occur

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not exceed recommended dosage.



Adults and children
over 12 years
of age:


1 teaspoonful (5 mL)
every 4 to 6 hours,
not to exceed 6
teaspoonfuls in a
24 hour period.
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 a
24 hour period.
Children under
6 years of age:
Not recommended
for use.

Other information

Sote at 59o - 86oF (15o - 30oC)

Inactive ingredients

Bubble Gum Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Raspberry Flavor, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number. Call 1-866-991-9871
Mon. - Fri. (8 a.m. to 5 p.m. CST).

PRODUCT PACKAGING:

The packaging below represents the labeling currently used:

Principal Display Panel and Side Panel:

NDC 15310-090-16

Alcohol Free - Dye Free
Sugar Free

PluratussTM

Antihistamine - Antitussive

Decongestant

Each 5 mL (1 teaspoonful) for oral administration contains:
Brompheniramine Maleate........ 4 mg
Codeine Phosphate................. 10 mg
Phenylephrine HCl.................. 7.5 mg

CV

Raspberry-Bubble Gum Flavor

Rx Only

Creekwood Pharmaceutical, Inc.

16 fl. oz. (473 mL)


Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container with a child-resistant closure.

This bottle is not to be dispensed to consumer.

Manufactured by: Great Southern Laboratories, Houston, TX 77099

Manufactured for: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242

Rx Only

Iss. 12/09

Pluratuss Product Packaging
Pluratuss Product Packaging

PLURATUSS 
brompheniramine maleate, codeine phosphate, and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15310-090
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Brompheniramine Maleate (UNII: IXA7C9ZN03) (Brompheniramine - UNII:H57G17P2FN) Brompheniramine Maleate4 mg  in 5 mL
Codeine Phosphate (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) Codeine Phosphate10 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride7.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
Color    Score    
ShapeSize
FlavorRASPBERRY, BUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15310-090-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/06/201003/31/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/06/201003/31/2011
Labeler - Creekwood Pharmaceutical, Inc. (618997188)

Revised: 11/2016
 
Creekwood Pharmaceutical, Inc.