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NDC 76281-0506-28 Day Time Non-Drowsy Cold - Flu Relief 325; 10; 5 mg/15mL; mg/15mL; mg/15mL Details
Day Time Non-Drowsy Cold - Flu Relief 325; 10; 5 mg/15mL; mg/15mL; mg/15mL
Day Time Non-Drowsy Cold - Flu Relief is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by AptaPharma Inc.. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 76281-0506-28Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 76281-0506-28Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 76281-0506-28Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 76281-0506 |
|---|---|
| Product ID | 76281-506_e9c7454c-8f8b-43e6-a836-15c5fd981e9a |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Day Time Non-Drowsy Cold - Flu Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 325; 10; 5 |
| Active Ingredient Units | mg/15mL; mg/15mL; mg/15mL |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | AptaPharma Inc. |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 76281-0506-28 (76281050628)
| NDC Package Code | 76281-506-28 |
|---|---|
| Billing NDC | 76281050628 |
| Package | 354 mL in 1 BOTTLE, PLASTIC (76281-506-28) |
| Marketing Start Date | 2018-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c0dc613c-7f4e-4733-b2b6-6ba20e8fb83c Details
Active Ingredients(in each 15 mL, 1 tablespoon)
Uses
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if ■ adult takes more than 4,000 mg of acetaminophen in 24 hours ■ child takes more than 5 doses in 24 hours ■ taken with other drugs containing acetaminophen ■ adult has 3 or more alcoholic drinks every day while using 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
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.
Ask a doctor before use if you have
When using this product
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.
Overdose Warning:
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.
Inactive Ingredients
Product Package Label
NDC 76281-506-28
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
Non-Drowsy
Cold & Flu Relief
Multi-Symptom Relief
12 FL OZ (354 mL)
DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences
Drug Facts
Active Ingredients (in each 15 mL, 1 tablespoon) Purpose
Acetaminophen 325 mg……………………………............…Pain reliever/fever reducer
Dextromethorphan HBr 10 mg………………………….………Cough suppressant
Phenylephrine HCI 5 mg………………………………………..Nasal decongestant
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
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if ■ adult takes more than 4,000 mg of acetaminophen in 24 hours ■ child takes more than 5 doses in 24 hours ■ taken with other drugs containing acetaminophen ■ adult has 3 or more alcoholic drinks every day while using 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
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.
Ask a doctor before use if you have
■ liver disease ■ heart disease ■ thyroid disease ■ diabetes
■ high blood pressure ■ trouble urinating due to enlarged prostrate gland
■ persistent or chronic cough such as occurs with smoking, asthma, or
emphysema ■ cough accompanied by excessive phlegm (mucus)
Ask a doctor or pharmacist before use if you are taking the blood thinning
drug warfarin
When using this product ■ do not use more than directed (see overdose
warning) ■ avoid alcoholic drinks
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 ►
Drug Facts (continued)
■ 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 could
be signs of a serious condition.
If pregnant or breast-feeding ask a health professional before use.
Keep this and all drugs out of the reach of children.
Overdose Warning: Taking more than the recommended dose (overdose) may
cause liver damage. In case of accidental overdose, get medical help or contact
a Poison Control Center right away. Prompt medical attention is critical for adults
as well as for children even if you do not notice any signs or symptoms.
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.
Other information ■ sodium content per tablespoon: 10 mg
■ store at room temperature
Inactive ingredients citric acid, FD&C Yellow # 6, Made in USA
flavor, glycerin, propylene glycol, purified water, AP-LR-07
saccharin sodium, sodium benzoate, sucrose
Questions? Call weekdays from 9:30 AM to
4:30 PM EST at 1-877-798-5944
*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:
6 OZ
res
INGREDIENTS AND APPEARANCE
| DAY TIME NON-DROWSY COLD - FLU RELIEF
acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid |
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| Labeler - AptaPharma Inc. (790523323) |
| Registrant - AptaPharma Inc. (790523323) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| AptaPharma Inc. | 790523323 | manufacture(76281-506) , pack(76281-506) , label(76281-506) | |