Label: ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE- acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride tablet, coated
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- NDC Code(s): 57344-128-02
- Packager: AAA Pharmaceutical, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 12, 2019
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- headache
- sinus congestion and pressure
- nasal congestion
- runny nose and sneezing
- minor aches and pains
- temporarily relieves these additional symptoms of hay fever:
- itching of the nose or throat
- itchy, watery eyes
- helps clear nasal passages
- helps decongest sinus openings and passages
- temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
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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
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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion 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
These could be signs of a serious condition.
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.
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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
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton
NDC 57344-128-02
RESTORE u
†COMPARE TO THE ACTIVE
INGREDIENTS IN TYLENOL®
ALLERGY MULTI-SYMPTOMAllergy
MULTI-SYMPTOM
Pain Reliever, Nasal Decongestant, Antihistamine- Headache - Acetaminophen
- Sinus Pressure
- Nasal Congestion
Phenylephrine HCl - Runny Nose/Sneezing
- Itchy, Watery Eyes
Chlorpheniramine Maleate
COOL TASTE
MAY CAUSE DROWSINESS
24 CAPLETS
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-128 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (Off-White) Score no score Shape OVAL Size 17mm Flavor MINT Imprint Code AAA;1117 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57344-128-02 2 in 1 CARTON 08/02/2012 1 12 in 1 BLISTER PACK; 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 08/02/2012 Labeler - AAA Pharmaceutical, Inc. (181192162)