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 Selder, S.A. de C.V., 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

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Antihistamine

Antitussive

Nasal decongestant

Uses

temporarily relieves: muscular 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 pressure 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 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.

Allergy 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

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor if you are allergic to acetaminophen or any of the inactive ingredients in 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 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 glaucoma 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 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 alcohlic beverages

Stop use and aska doctor

symptoms do not improve pain, nasal congestion or cough gets worse or lasts more than 7 days redness or swelling is present new symptoms occur cough comes back or occurs with a rash or a headache tha lasts. These could be the signs of a serious condition nervousness, dizziness, or sleeplessness occur 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 the 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) do not take this product form 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 the recommended dose (overdoes) may cause liver damage. Do not exceed recommended dosage

Other information

Store at room temperature to 15º-30ºC (59º-86ºF) do not use if package is torn or damaged

Inactive ingredients

D&C red no. 33, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, propylene glycol, purified water

Questions and Comments?

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

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: 63654-800
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 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: 63654-800-20	20 in 1 BLISTER PACK; Type 0: Not a Combination Product	11/15/2011	10/15/2018
2	NDC: 63654-800-12	12 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/22/2014
3	NDC: 63654-800-06	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	11/15/2011

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

Establishment
Name	Address	ID/FEI	Business Operations
Selgel México, S.A. de C.V.		812296782	manufacture(63654-800)