COLD MEDICINE XL3- acetaminophen chlorpheniramine maleate phenylepherine hydrochloride tablet

Cold Medicine by

Drug Labeling and Warnings

Cold Medicine by is a Otc medication manufactured, distributed, or labeled by Selder, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each capsule)
Acetaminophen 325 mg
Chlorpheniramine Maleate 4 mg
Phenylepherine Hydrochloride 10 mg

PURPOSE

Purpose
Analgesic
Antihistamine
Decongestant

INDICATIONS & USAGE

Uses  temporarily relieves these symptoms due to common cold and allergies: nasal congestion runny nose sneezing watery eyes fever aches and pains

WARNINGS

Warnings
Do exceedrecommended dosage

ASK DOCTOR

Ask a doctor before use you have
glaucoma breathing problem such as emphysema or chronic bronchitis heart disease diabetes thyroid disease 
difficulty in urination due to enlargement of the prostate gland

ASK DOCTOR/PHARMACIST

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

STOP USE

Stop taking this product and ask a doctor if you have pain fever or symptoms that persist or get worse new symptoms occur
redness or swelling these may be signs of a serious condition.

WHEN USING

When using this product
you may get drowsy avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
  excitability may occur, especially in children

If nervousness, dizziness or sleeplessness occur discontinue use and consult a doctor

If symptoms do not improve within 7 days, or are accompanied by fever, consult a doctor

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

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

SPL UNCLASSIFIED SECTION

Drug Interaction Precautions
Do not use if you are 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.

DOSAGE & ADMINISTRATION

Directions Adults and children 12 years of age and older; take 1 tablet every 4 hours, do not take more than 6 tablets in 24 hours, unless directed by a doctor.

INACTIVE INGREDIENT

Inactive Ingredients Lactose, stearic acid, povidone, hydroxypropylmethylcellulose, polyethylene glycol, titanium dioxide, FDC Yellow No. 5

PRINCIPAL DISPLAY PANEL

Package Label

INGREDIENTS AND APPEARANCE

COLD MEDICINE  XL3
acetaminophen chlorpheniramine maleate phenylepherine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63654-600
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE (UNII: FZ989GH94E)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	yellow (light yellow)	Score	no score
Shape	ROUND (Tablet)	Size	5mm
Flavor		Imprint Code	XL;3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63654-600-68	20 in 1 BLISTER PACK
2	NDC: 63654-600-02	25 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/15/2011

Labeler - Selder, S.A. de C.V. (824413629)

Establishment
Name	Address	ID/FEI	Business Operations
Selder, S.A. de C.V.		824413629	manufacture