Drug Facts
Cold Relief Tablets
Active Ingredients (in each tablet)
Acetaminophen 325 mg
Guaifenesein 200 mg
Phenylephrine HCl 5 mg
Dextromethorphan HBr 15 mg
Aramark Multi-symptom Cold Relief
FDA Label NDC 81238-0107
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Western First Aid Safety Dba Aramark for the product Aramark Multi-symptom Cold Relief (NDC 81238-0107). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - ask doctor, pregnancy, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Acetaminophen.....................Pain Reliever/Fever Reducer
Guaifenesein ........................Expectorant
Phenylephrine HCl ...............Decongestant
Dextromethorphan HBr. .......Antitussive
Indications & Usage
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
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
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
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
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
If pregnant or breast-feedin baby, ask a health
professional before use.
Otc - Keep Out Of Reach Of Children
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
| 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
Inactive Ingredients:
Maltodextrin, Microcrystalline Cellulose, Povidone,
Sodium Starch Glycolate, Starch, Stearic Acid
Product Labeling
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
250 Tablet Box
2-Tablet Packet
res
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