COUGH AND COLD XL3 XTRA- acetaminophen chlorpheniramine maleate dextromethorphan hydrobromide phenylepherine hydrochloride capsule, liquid filled

Cough and Cold by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients (in each capsule)

Acetaminophen 250 mg
Chlorpheniramine Maleate 2 mg
Dextromethorphan Hydrobromide 10 mg

Phenylepherine Hydrochloride 5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Antitussive (cough suppressant)

Nasal decongestant

Uses

temporarily relieves: ▪ minor aches and pains ▪ headache ▪ temporarily reduces fever ▪ runny nose ▪ sneezing ▪ itching of the nose or throat

▪ itchy, watery eyes due to hay fever or other upper respiratory allergies ▪ nasal congestion ▪ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take ▪ more than 12 capsules 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

Do not exceed recommended dosage

Do not use

▪ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ▪ if you are allergic to acetaminophen or any of the inactive ingredients in this product in excess of recommended dosage ▪ 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 ▪ for persistent or chronic cough such as occurs when smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor ▪if you are taking sedatives or tranquilizers, without first consulting your doctor.

Ask a doctor before use if you have

▪ liver disease ▪ a breathing problem such as emphysema or chronic bronchitis ▪ glaucoma ▪ heart disease ▪ high blood pressure

▪ thyroid disease ▪ diabetes ▪ difficulty in urination due enlargement of the prostate gland.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

▪ excitability may occur, especially in children ▪ may cause drowsiness ▪ alcohol, sedatives and tranquilizers may increase drowsiness effect

▪ use caution when driving a motor vehicle or operating machinery ▪ avoid alcoholic beverages

Stop use and ask a doctor if

▪ pain, nasal congestion or cough gets worse or lasts more than 7 days ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ cough comes back or occurs with rash or headache that lasts.These could be signs of a serious condition. ▪ nervousness, dizziness, or sleeplessness occur.

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 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 take more than directed (see overdose warning) ▪ do not use for more than 10 days unless directed by a doctor ▪ Adults and children 12 years of age and over ▪ take 2 capsule every 4 hours. ▪ do not take more than 12 capsules in 24 hours ▪ Children under 12 years of age ▪ do not use this adult product in children under 12 years of age; this will provide more than recommended dose (overdoes) and may cause liver damage.

Other Information

Store at room temperature in a dry place

Inactive Ingredients

DC red no. 33, FDC blue no. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, propylene glycol, water

Package Label

INGREDIENTS AND APPEARANCE

COUGH AND COLD  XL3 XTRA
acetaminophen chlorpheniramine maleate dextromethorphan hydrobromide phenylepherine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58596-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue (Sky Blue)	Score	no score
Shape	CAPSULE (Soft liquid filled capsule)	Size	10mm
Flavor		Imprint Code	Xtra
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58596-001-12	12 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/22/2014
2	NDC: 58596-001-06	6 in 1 BLISTER PACK; Type 0: Not a Combination Product	10/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/31/2014

Labeler - Selgel México, S.A. de C.V. (812296782)

Establishment
Name	Address	ID/FEI	Business Operations
Selgel México, S.A. de C.V.		812296782	manufacture(58596-001)