NDC 68210-4083 Multi-symptom Daytime

Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride

NDC Product Code 68210-4083

NDC CODE: 68210-4083

Proprietary Name: Multi-symptom Daytime What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

Product Characteristics

Color(s):
ORANGE (C48331 - ORANGE TO RED)
Shape: CAPSULE (C48336)
Size(s):
21 MM
Imprint(s):
512
Score: 1

NDC Code Structure

  • 68210 - Spirit Pharmaceuticals Llc

NDC 68210-4083-1

Package Description: 4 BLISTER PACK in 1 CARTON > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Multi-symptom Daytime with NDC 68210-4083 is a a human over the counter drug product labeled by Spirit Pharmaceuticals Llc. The generic name of Multi-symptom Daytime is acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Spirit Pharmaceuticals Llc

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Multi-symptom Daytime Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 325 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POVIDONE K30 (UNII: U725QWY32X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Spirit Pharmaceuticals Llc
Labeler Code: 68210
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-02-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Multi-symptom Daytime Product Label Images

Multi-symptom Daytime Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Otc - Purpose

Active ingredients (in each softgel)PurposeAcetaminophen 325 mgPain reliever/fever reducerDextromethorphan Hydrobromide 10 mgCough suppressantPhenylephrine HCl 5 mgNasal decongestant

Uses

  • Temporarily relieves common cold/flu symptoms:nasal congestioncough due to minor throat & bronchial irritationsore throatheadacheminor aches/painsfever

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur if you take:more than 4 doses in 24 hours, which is the maximum daily amount for this productwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product

Allergy Alert:

  • Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddeningblistersrash

Sore Throat Warning:

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Otc - Do Not Use

  • 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 diseaseheart diseasethyroid diseasediabeteshigh blood pressuretrouble urinating due to enlarged prostate glandcough that occurs with too much phlegm (mucus)persistent or chronic cough as occurs with smoking, asthma, or emphysema

Otc - Ask Doctor/Pharmacist

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.

Stop Use And Ask A Doctor If

  • You get nervous, dizzy, or sleeplesspain, nasal congestion or cough gets worse or last more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough comes back, or occurs with rash or headache that lastsThese could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children, even if you do not notice any signs or symptoms.

Directions

  • Take only as directed—see
  • Overdose warning.
  • Do not exceed 4 doses per 24 hours.adults and children 12 years of age and overswallow 2 softgels with water every 4 hourschildren 4 to under 12 years of ageask a doctorchildren under 4 years of agedo not useIf taking Daytime and Nighttime softgels carefully read each label to insure correct dosing

Other Information

  • Store at room temperature 15°-30°C (59°-86°F) and avoid excessive heatthis product does not contain phenylpropanolamine

Inactive Ingredients

FD&C Red No. 40, FD&C Yellow No.6. gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

* Please review the disclaimer below.