9/2/14 Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride (AAA Pharmaceutical, Inc.

) ACETAMINOPHEN
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Acetaminophen, Chlorpheniramine Maleate,
Dextromethorphan Hydrobromide, Phenylephrine
Hydrochloride
Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, DEXTROMETHORPHAN
HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: AAA Pharmaceutical, Inc.
NDC Code: 57344-139
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable
regulations and policies. FDA has not evaluated whether this product complies.
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl Tablets
Drug Facts
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever/f ever reducer
Chlorpheniramine maleate 2 mg Antihistamine
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
Uses
temporarily relieves these common cold/flu symptoms:
minor aches and pains
headache
sore throat
nasal congestion
runny nose and sneezing
cough
sinus congestion and pressure
helps clear nasal passages
relieves cough to help you sleep
temporarily reduces fever
Warnings
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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 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
high blood pressure
diabetes
heart disease
thyroid disease
glaucoma
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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
taking sedatives or tranquilizers
When using this product
do not exceed recommended dosage
excitability may occur, especially in children
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
9/2/14 Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride (AAA Pharmaceutical, Inc.) ACETAMINOPHEN
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Stop use and ask a doctor if
nervousness, dizziness, or sleeplessness occur
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.
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 (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 overdose warning)
adults and children 12
years and over
take 2 caplets every 4 hours
swallow whole do not crush, chew, or dissolve
do not take more than 12 caplets in 24 hours
children under 12
years
do not use this adult product in children under 12 years of age; this will provide more than the
recommended dose (overdose) and may cause liver damage
Other information
store between 20-25C (68-77F) in a dry place
retain carton for complete product information
Inactive ingredients
acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, flavor, magnesium
stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch,
propylene glycol, stearic acid, talc, titanium dioxide
Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048
PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton
RESTORE u
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NDC 57344-139-02
COMPARE TO THE ACTIVE
INGREDIENTS IN TYLENOL
COLD MULTI-SYMPTOM -
NIGHTTIME
NIGHTTIME
Cold
MULTI-SYMPTOM
Pain Reliever/Fever Reducer, Nasal Decongestant,
Cough Suppressant, Antihistamine
Headache/Sore Throat Acetaminophen
Nasal Congestion Phenylephrine HCl
Coughing Dextromethorphan HBr
Runny Nose Chlorpheniramine Maleate
COOL BLAST
24 CAPLETS

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9/2/14 Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride (AAA Pharmaceutical, Inc.) ACETAMINOPHEN
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ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE
HYDROCHLORIDE
acetaminophen, chlorpheniramine maleate, dextromethorphan hy drobromide, and pheny lephrine hy drochloride tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-139
Route of Administration ORAL DEASchedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 2 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
POVIDONES
STARCH, CORN
PROPYLENE GLYCOL
STEARIC ACID
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 17mm
Flavor MINT Imprint Code AAA;1139
Contains
Packaging
# Item Code Package Description
1 NDC:57344-139-02 2 BLISTER PACK in 1 CARTON
9/2/14 Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride (AAA Pharmaceutical, Inc.) ACETAMINOPHEN
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AAA Pharmaceutical, Inc.
1 12 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 12/28/2012
Labeler -
AAA Pharmaceutical, Inc. (181192162)
Revised: 01/2013

See all Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine
Hydrochloride brands
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee
is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare
practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be
construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the
substances you are taking, check with your doctor, nurse or pharmacist.
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