Daytime Severe Cold and Flu

Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:43:28

Label at a glance#

ProductDaytime Severe Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

• for the temporary relief of the following cold/flu symptoms: • minor aches and pains • headache • sore throat • nasal congestion • cough • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive • temporarily reduces fever

Dosage and administration

do not take more than directed  adults and children 12 years & 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

Storage and handling

store at 25ºC (77ºF); excursions permitted between 15º–30ºC (59º–86ºF)

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

• for the temporary relief of the following cold/flu symptoms: • minor aches and pains
• headache • sore throat • nasal congestion • cough • helps loosen phlegm (mucus) and thin
bronchial secretions to make coughs more productive • temporarily reduces fever

Warnings

WARNINGS SECTION

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

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

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

• 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)

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed

 adults and children 12 years & 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

STORAGE AND HANDLING SECTION

store at 25ºC (77ºF); excursions permitted between 15º–30ºC (59º–86ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C Yellow#10, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone*, pregelatinized starch, talc, titanium dioxide *may contain this ingredient

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

Distributed by:

SPL UNCLASSIFIED SECTION

Cabinet Health P.B.C.

Principal Display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton BackCarton BackCarton FrontCarton Front

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1110988acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN4
1110988acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD4
1110988APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4231-3Daytime Severe Cold and Flu30 in 1 POUCHTABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4231DAYTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC]4Legacy NDC, 1 package rows20241215_aeedc6e3-e563-464a-8e20-7bff38557556.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-423168210-4231-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
292d319c-6fbe-8ada-e063-6294a90a0c79aeedc6e3-e563-464a-8e20-7bff385575562024-12-13WarningsExact identifier
spl id: 292d319c-6fbe-8ada-e063-6294a90a0c79
spl set id: aeedc6e3-e563-464a-8e20-7bff38557556

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.