MEDIQUE CCP CAFFEINE FREE- acetaminophen, guaifenesin, phenylephrine hydrochloride tablet

Medique CCP Caffeine Free by

Drug Labeling and Warnings

Medique CCP Caffeine Free by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine Hydrochloride 5 mg

Purpose

Pain reliever/ fever reducer

Expectorant

Nasal decongestant

Uses

Temporarily relieves minor aches and pains associated with

■ headache

■ muscular aches

■ minor arthritis pain

■ common cold

■ toothache

■ menstrual cramps

Temporarily relieves nasal congestion due to

■ common cold

■ hay fever or other respiratory allergies

Temporarily

■ reduces fever

■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

■ promotes nasal and/or sinus drainage; relieves sinus congestion and pressure

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
• with any other drug using the above active ingredients
• 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.

Ask a doctor before use if you have

• liver disease
• thyroid disease
• diabetes
• high blood pressure
• heart disease
• difficulty in urination due to enlargement of the prostate gland
• a persistent chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

Stop use and ask a doctor if

• cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
• symptoms do not improve within 7 days or are accompanied by a fever
• pain or fever persists or gets worse
• redness or swelling is present
• any new symptoms occur

Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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

Adults and children: (12 years and older) Take 2 tablets every 4 hours. Do not take more
than 12 tablets in 24 hours.

Swallow whole-do not crush, chew or dissolve.

Children under 12 years: Do not give to children under 12 years of age this will
provide more than the recommended dose (overdose) and
may cause liver damage.

Other information

• store at room temperature 59º-86ºF (15º-30ºC)
• tamper evident sealed packets
• do not use any opened or torn packets
• avoid excessive heat and humidity

Inactive ingredients

FD&C red #40, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

Questions or comments?

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CCP Caffeine Free

Cold, Cough and Flu Relief

Mejora el Resfriado, la Tos y la Gripe

Pain Reliever/ Fever Reducer ● Acetaminophen 325mg

Alivia el dolor/ Reduce la fiebre ● Acetaminofeno 325mg

Expectorant ● Guaifenesin 200mg

Expectorante ● Guaifenesina 200mg

Nasal Decongestant ● Phenylephrine HCl 5mg

Decongestivo nasal● Hidrocloruro de fenilefrina 5mg

Pull to Open

Tire Para Abrir

This Package Is For Households Without Young Children

Este Paquete Es Para Hogares Sin Ninos Pequenos

500 Tablets

(250 x 2)

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Untarias

INGREDIENTS AND APPEARANCE

MEDIQUE CCP CAFFEINE FREE 
acetaminophen, guaifenesin, phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-168
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	pink (pink)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor		Imprint Code	FR;14
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-168-33	50 in 1 BOX	08/01/2011
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-168-13	250 in 1 BOX	08/01/2011
2	NDC: 47682-168-99	2 in 1 PACKET; 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	08/01/2011

Labeler - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		170837962	relabel(47682-168) , repack(47682-168)