COLD MEDICINE XL3 FORTE- 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 ingredients (in each tablet)

Acetaminophen 325 mg
Chlorpheniramine maleate 4 mg
Phenylepherine HCl 10 mg

Purposes

Pain reliever/fever reducer
Antihistamine
Nasal decongestant

Uses

temporarily relieves ■ minor aches and pains ■ headaches ■ nasal congestion ■ sinus congestion & pressure ■ runny nose ■sneezing

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 6 tablets in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product

Alergy alert acetaminophen may cause severe skin reactions. Symptoms may include ■ skin reddening ■ blisters ■ rash

If a skin reaction occurs, stop use and seek medical help right away

Do not use

■ If you are allergic to acetaminophen ■ more than 10 days unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor ■ if you are taking a 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 contasins an MAOI, ask a doctor or pharmacist before taking this product. ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask adoctor before use if you have

■ liver disease ■ heart disease ■ glaucoma ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you

■ are taking the blood thinning drug warfarin ■ are taking sedatives or tranquilizers

When using this product

■ do not use more than directed ■ excitability may occur, especially in children ■ may cause drowsiness ■ alcohol, sedatives and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

■ redness or swelling is present ■ new symptoms occur ■ you get nervous, dizzy, or sleepless ■ pain or nasal congestion gets worse or lasts for more than 7 days ■ fever gets worse or lasts for more than 3 days

Keep out of reach of children

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

■ Do not use more than directed (see overdose warning) ■ 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 ■ Children under 12 years of age: do not use because this product contains to much medication for children under this age.

Other Information

■ store at room temperature 59-86F (15-30C) ■ do not use if package is torn or damaged

Inactive Ingredients

Lactose monohydrate (derived from milk), Stearic acid, Povidone, Alcohol, Water purified, Hypromellose, Titanium dioxide, Triacetin, contains FDC Yellow No. 5 (tartrazine) as color additive

Questions and Comments?

You may report side effects to 1-855-259-1590 Monday through Friday 9AM-5PM EST

Package Label

INGREDIENTS AND APPEARANCE

COLD MEDICINE  XL3 FORTE
acetaminophen chlorpheniramine maleate phenylepherine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63654-601
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
TRIACETIN (UNII: XHX3C3X673)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE (UNII: FZ989GH94E)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Product Characteristics
Color	yellow (light yellow)	Score	no score
Shape	ROUND (Tablet)	Size	5mm
Flavor		Imprint Code	XL3;FORTE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63654-601-50	50 in 1 BOX	08/01/2017
1	NDC: 63654-601-04	4 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 63654-601-20	2 in 1 BOX	08/01/2017
2	NDC: 63654-601-02	10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 63654-601-10	1 in 1 BOX	10/12/2018
3	NDC: 63654-601-01	10 in 1 BLISTER PACK; 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	08/01/2017

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

Establishment
Name	Address	ID/FEI	Business Operations
Selder, S.A. de C.V.		824413629	manufacture(63654-601)