APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet

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Pill Identifier Information of APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet

Drug Information

Imprint:	L402
Shape:	C48336
Color:	C48325
Ingredients:	Acetaminophen; Dextromethorphan; Phenylephrine
Size:	17.00
Score:	1
Rxtty:	SY
Author:	Physicians Total Care, Inc.
Inactive Ingredients:	ACESULFAME POTASSIUM / CARNAUBA WAX / MAGNESIUM STEARATE / CELLULOSE, MICROCRYSTALLINE / POLYETHYLENE GLYCOL / POLYVINYL ALCOHOL / POVIDONE / SILICON DIOXIDE / STEARIC ACID / TALC / TITANIUM DIOXIDE>

Complete Information

Active ingredient (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg
Purpose

Pain reliever

Cough suppressant

Nasal decongestant
Uses
- temporarily relieves these common cold symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- cough
- sinus congestion and pressure
- helps clear nasal passages
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 caplets 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
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinsonâ€™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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin

When using this product
do not use more than directed
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- 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.
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. (1-800-222-1222) 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 Liver warning)

adults and children 12 years and over	take 2 caplets every 4 hours do not take more than 12 caplets in 24 hours swallow whole â€“ do not crush, chew or dissolve
children under 12 years	do not use this adult product in children under 12 years of age

Other information
- store at 20Â°-25Â°C (68Â°-77Â°F)
Inactive ingredients

acesulfame potassium, carnauba wax, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide
Questions or comments?

1-800-719-9260
Principal Display Panel

See New Warnings Information

Compare to active ingredients in TylenolÂ® Cold Head Congestion Daytime Caplets

Cold

Head Congestion

Pain Reliever, Cough Suppressant, Nasal Decongestant

Contains 3 Medicines:

Headache/Sore Throat â€“ Acetaminophen

Nasal Congestion â€“ Phenylephrine HCl

Coughing â€“ Dextromethorphan HBr

Cool IceÂ® Instant Cooling Sensation

Daytime

Non-Drowsy

NDC 54868-6233-0

Cold Head Congestion Package Label

INGREDIENTS AND APPEARANCE

COLD HEAD CONGESTIONÂ
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54868-6233(NDC:24385-197)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325Â mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10Â mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5Â mg

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)	Â
CARNAUBA WAX (UNII: R12CBM0EIZ)	Â
MAGNESIUM STEARATE (UNII: 70097M6I30)	Â
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)	Â
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)	Â
POLYVINYL ALCOHOL (UNII: 532B59J990)	Â
POVIDONE (UNII: FZ989GH94E)	Â
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	Â
STEARIC ACID (UNII: 4ELV7Z65AP)	Â
TALC (UNII: 7SEV7J4R1U)	Â
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	Â

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	L402
Contains	Â Â Â Â

#	Item Code	Package Description
Packaging
1	NDC:54868-6233-0	2 in 1 CARTON
1		12 in 1 BLISTER PACK

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	02/16/2011

Labeler -Â Physicians Total Care, Inc. (194123980)

Name	Address	ID/FEI	Business Operations
Establishment
Physicians Total Care, Inc.		194123980	relabel