Label: COLD AND SORE THROAT- acetaminophen, pheniramine maleate, phenylephrine hydrochloride powder
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- NDC Code(s): 73147-3173-6
- Packager: Cellchem Pharmaceuticals 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 November 28, 2022
If you are a consumer or patient please visit this version.
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Drug Facts
Active Ingredients (in each packet) Purpose
Acetaminophen 325 mg...................................................Pain reliever/Fever reducer
Pheniramine maleate 20 mg................................................Antihistamine
Phenylephrine Hydrochloride 10 mg......................................Nasal decongestant
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Uses
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- Temporarily relieves these symptoms due to cold:
- o
- minor aches and pains
- o
- minor sore throat pain
- o
- headache
- o
- nasal congestion
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- Temporarily reduces fever
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- Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- o
- runny nose
- o
- sneezing
- o
- itchy nose and throat
- o
- itchy, watery eyes
- INDICATIONS & USAGE
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
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- more than 6 packets in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include
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- skin reddening
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- blisters
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- rash. If a skin reaction occurs, stop use and seek medical help right away.
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
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- in children under 12 years of age
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- if you are allergic to acetaminophen
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- with any other drug containing acetaminophen (prescription and non-prescription). If you are not sure whether a drug contains cetaminophen, ask a doctor or pharmacist.
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- 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 a MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- glaucoma
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- trouble urinating due to an enlarged prostate gland
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- a breathing problem such as emphysema, asthma, or chronic bronchitis
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- a sodium restricted diet.
Ask a doctor or pharmacist before use if you are
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- taking sedatives or tranquilizers
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- taking the blood thinning drug warfarin
When using this product
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- do not exceed recommended dosage
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- avoid alcoholic drinks
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- may cause drowsiness
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- alcohol, sedatives, and tranquilizers may increase drowsiness
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- be careful when driving a motor vehicle or operating machinery
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- excitability may occur, especially in children.
Stop use and ask a doctor if
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- nervousness, dizziness, or sleeplessness occurs
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- pain or nasal congestion gets worse or lasts more than 7 days
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- fever gets worse or lasts more than 3 days
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- new symptoms occur
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- redness or swelling is present These could be signs of a serious condition.
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Directions
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- do not use more than directed
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- take every 4 hours, while symptoms persist.
Do not take more than 6 packets in 24 hours unless directed by a doctor.
Age
Dose
adults and children 12 years and over
one packet
children under 12 years
do not use
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- dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
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- if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
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- Inactive ingredients
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- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COLD AND SORE THROAT
acetaminophen, pheniramine maleate, phenylephrine hydrochloride powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73147-3173 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M) PHENIRAMINE MALEATE 20 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) STARCH, CORN (UNII: O8232NY3SJ) RAW SUGAR (UNII: 8M707QY5GH) ASCORBIC ACID (UNII: PQ6CK8PD0R) Product Characteristics Color Score Shape Size Flavor LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73147-3173-6 6 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product 07/01/2019 12/31/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/01/2019 12/31/2023 Labeler - Cellchem Pharmaceuticals Inc (111518618) Registrant - Cellchem Pharmaceuticals Inc (111518618) Establishment Name Address ID/FEI Business Operations Laboratoires Confab Inc 241754217 MANUFACTURE(73147-3173)
