NDC | 57344-163-02, 57344-163-05 |
Set ID | a242e005-0330-4afb-83b8-13c7d56f5c6d |
Category | HUMAN OTC DRUG LABEL |
Packager | AAA Pharmaceutical, Inc. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
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
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
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.
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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 10 caplets in 24 hours
children under 12 years - ask a doctor
- Other information
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Inactive ingredients
acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, D&C yellow #10, FD&C blue #2, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton
RESTORE u
NDC 57344-163-05
†COMPARE TO THE ACTIVE
INGREDIENTS IN TYLENOL ®
COLD & FLU SEVERESee New Warnings
Information & DirectionsDAYTIME
NON-DROWSYSevere Cold & Flu
For
AdultsPain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant, Expectorant
- Headache/Fever/Sore Throat – Acetaminophen
- Nasal Congestion – Phenylephrine HCl
- Coughing – Dextromethorphan HBr
- Chest Congestion, Clears out Mucus – Guaifenesin
24 CAPLETS
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-163 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color yellow Score no score Shape OVAL Size 19mm Flavor MINT Imprint Code AAA;1136 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57344-163-02 2 in 1 CARTON 08/02/2012 10/31/2017 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:57344-163-05 2 in 1 CARTON 10/28/2015 2 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)