Aramark Multi-Symptom Cold Relief

Manufacturer
Western First Aid Safety DBA Aramark | ULTRA SEAL CORPORATION
Effective date
2021-06-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:44

Label at a glance#

ProductAramark Multi-Symptom Cold Relief
Active ingredientACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure13 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Cold Relief Tablets
Active Ingredients (in each tablet)
Acetaminophen 325 mg
Guaifenesein 200 mg
Phenylephrine HCl 5 mg
Dextromethorphan HBr 15 mg

OTC - PURPOSE SECTION

Purpose
Acetaminophen.....................Pain Reliever/Fever Reducer
Guaifenesein ........................Expectorant
Phenylephrine HCl ...............Decongestant
Dextromethorphan HBr. .......Antitussive

INDICATIONS & USAGE SECTION

Uses: temporarily:
• relieves nasal congestion associated with sinusitis
• relieves nasal confestion due to the common cold, hay
  fever or other respiratory allergies
• relieves sinus congestion and pressure, helps
  decongest sinus openings and passages
• restores free breathing
• helps loosen phlegm (mucus) and thin bronchial
  secretions to rid the bronchial passages of
  bothersome mucus, drain bronchial tubes, and make
  coughs more productive
• temporarily suppresses cough due to minor throat
  and bronchial irritation associated with a cold or
  inhaled irritants
Temporarily relieves minor aches, pains and fever
associated with: • headache • backache • common
cold • muscular aches • toothache • menstrual cramps
o make coughs more productive

WARNINGS SECTION

Warnings:
Liver Warning: This product containsacetaminophen.
Severe liver damage may occur if you take:
• more than 8 tablets in 24 hours
• with other drugs containing acetaminophen
  (prescription or nonprescription)
• Ask a doctor or pharmacist before using with other
  drugs if you are not sure
• 3 or more alcoholic drinks every day while using
  this product.

OTC - DO NOT USE SECTION

Do not:
• use with any other product containing
  acetaminophen. This will provide more than the
  recommended dose (overdose) of acetaminophen
  and could cause serious health concerns.
• use more than the recommended dose
• for more than 10 days for pain unless directed by
  a doctor
• for more than 3 days for fever unless directed by a
  doctor
• when using this product do not exceed
  recommended dose 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 MAOI drug. If you do not
  know if your prescription drug contains an MAOI,
  consult a doctor or pharmacist before taking this
  product

OTC - STOP USE SECTION

Stop use and ask a doctor if:

• symptoms do not improve
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present
• nervousness, dizziness or sleeplessness occur
• symptoms do not improve within 7 days or are
  accompanied by a fever
• cough persists for more than 1 week, tends
  to recur, or is
• accompanied by a fever, rash, or persistant headache.
• A persistant cough may be a sign of a serious
  condition

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have:
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the
  prostate gland
• persistent or chronic cough such as occurs with
  smoking,
• asthma, chronic bronchitis, or emphysema or where
  cough is
• accompanied by excessive phlegm (mucus)

PREGNANCY SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. 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.

DOSAGE & ADMINISTRATION SECTION

 Directions:
• Adults and children 12
  years of age and older:
Take 2 tablets every 6 to
8 hours as needed. Do
not exceed 8 tablets in 24
hours, or as directed by a
doctor.
• Children under 12 years:Consult a doctor.

OTHER SAFETY INFORMATION

Other Information:
Tamper evident. Do not use if packet is torn, cut or
opened Store at controlled room temperature 15° to
30°C (59° to 86° F) Avoid excessive heat and humidity

INACTIVE INGREDIENT SECTION

Inactive Ingredients:
Maltodextrin, Microcrystalline Cellulose, Povidone,
Sodium Starch Glycolate, Starch, Stearic Acid

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aramark

100 TABLETS            
PER BOX         Part # 82233B

Multi-Symptom
COLD RELIEF

Non-Pseudo Tablet
Decongestant

Temporary relief of minor
aches, pains, headache,
muscular aches, fever and
nasal congestion associated
with the common cold.

Compare active ingredient to:
DRISTAN Cold and Sinus®
Registered Trademark of Pfizer

Retain carton for complete product information

MANUFACTURED FOR:

Aramark
Lenexa, KS 66219
866-362-2691

aramarkuniform.com

100 Tablet Box

0107-100ct tab Box0107-100ct tab Box

250 Tablet Box

0107-2 250ct tab Box0107-2 250ct tab Box

2-Tablet Packet

0107 2-tab packet0107 2-tab packet

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1367204acetaminophen 325 MG / dextromethorphan HBr 15 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN1
1367204acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1
1367204APAP 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY1

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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
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e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
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b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81238-0107-12023-01-30C16284748780-1f386c64a-3af4-0266-e053-dadaa90a7c1aAramark Multi-Symptom Cold Relief
81238-0107-22023-01-30C16284748780-1f386c64a-3af4-0266-e053-dadaa90a7c1aAramark Multi-Symptom Cold Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81238-0107-1Aramark Multi-Symptom Cold Relief2 in 1 PACKETTABLET21
81238-0107-1Aramark Multi-Symptom Cold Relief50 in 1 BOXTABLET501
81238-0107-2Aramark Multi-Symptom Cold Relief2 in 1 PACKETTABLET21
81238-0107-2Aramark Multi-Symptom Cold Relief125 in 1 BOXTABLET1251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81238-0107ARAMARK MULTI-SYMPTOM COLD RELIEF (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR) TABLET [WESTERN FIRST AID SAFETY DBA ARAMARK]1Legacy NDC, 4 package rows20210605_88aee6e7-16d1-413b-af8c-32aee050c724.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81238-010781238-0107-1, 81238-0107-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
86f89604-3018-413b-b417-eb58b9d35f9588aee6e7-16d1-413b-af8c-32aee050c7242021-06-03WarningsExact identifier
spl id: 86f89604-3018-413b-b417-eb58b9d35f95
spl set id: 88aee6e7-16d1-413b-af8c-32aee050c724

Reported adverse events (FAERS/openFDA)#

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