Day-Time Cold/Flu Relief ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL APTAPHARMA INC. FDA Approved Uses temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ fever ■ nasal congestion ■ cough due to minor throat and bronchial irritation
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients (in each 15 mL 1 tablespoon) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCI 5 mg
Inactive Ingredients
Inactive Ingredients citric acid FD&C Yellow # 6 Made in USA flavor glycerin propylene glycol purified water saccharin sodium sodium benzoate sucrose
Strengths
15 ml 325 mg 10 mg 5 mg
Quantities
354 ml
Treats Conditions
Uses Temporarily Relieves These Common Cold Flu Symptoms Minor Aches And Pains Headache Sore Throat Fever Nasal Congestion Cough Due To Minor Throat And Bronchial Irritation

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D 9D2RTI9KYH 04JA59TNSJ
Packaging

Product Package Label - Day Time Cold & Flu Relief AP SAFE *COMPARE TO the active ingredients in VICKS® DAYQUIL® Day Time Acetaminophen – Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Phenylephrine HCI – Nasal Decongestant Cold & Flu Relief Multi-Symptom Relief 12 FL OZ (354 mL) *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil®. Manufactured by: AptaPharma Inc., 1533 Union Ave. Pennsauken, NJ 08110 LOT: EXP: 12 OZ res 506-28 12OZ

Package Descriptions
  • Product Package Label - Day Time Cold & Flu Relief AP SAFE *COMPARE TO the active ingredients in VICKS® DAYQUIL® Day Time Acetaminophen – Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Phenylephrine HCI – Nasal Decongestant Cold & Flu Relief Multi-Symptom Relief 12 FL OZ (354 mL) *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil®. Manufactured by: AptaPharma Inc., 1533 Union Ave. Pennsauken, NJ 08110 LOT: EXP: 12 OZ res 506-28 12OZ

Overview

Uses temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ fever ■ nasal congestion ■ cough due to minor throat and bronchial irritation

Indications & Usage

Uses temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ fever ■ nasal congestion ■ cough due to minor throat and bronchial irritation

Dosage & Administration

Directions ■ take only as recommended (see overdose warning) ■ use dosage cup or tablespoon (TBSP) ■ do not exceed 4 doses per 24 hours age dose adults & children 12 years and over 30 mL (2 TBSP) every 4 hours children 6 to under 12 years 15 mL (1 TBSP) every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use When using Day Time and Night Time products, carefully read each label to ensure correct dosing.

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes: ■ more than 4 doses in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks everyday while usina this product. Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ 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
Purpose

Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant

Do Not Use

Do not use ■ 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product. ■ for more than 10 days for pain unless directed by a doctor. ■ for more than 3 days for fever unless directed by a doctor. ■ with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacists.

When Using

When using this product ■ do not use more than directed (see overdose warning) ■ avoid alcoholic drinks

Stop Use & Ask a Doctor

Stop use and ask a doctor if ■ you get nervous, dizzy or sleepless ■ new symptoms occur ■ fever gets worse or lasts more than 3 days ■ pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) ■ redness or swelling is present ■ cough comes back or occurs with rash or headache that lasts. These couldbe signs of a serious condition.

Keep Out of Reach of Children

Keep this and all drugs out of the reach of children.

Questions

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944


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