Label: ARAMARK MULTI-SYMPTOM COLD RELIEF- acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hbr tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 81238-0107-1, 81238-0107-2 - Packager: Western First Aid Safety DBA Aramark
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 3, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
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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. -
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 -
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 -
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
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
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Product Labeling
aramark
100 TABLETS
PER BOX Part # 82233BMulti-Symptom
COLD RELIEFNon-Pseudo Tablet
DecongestantTemporary 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 PfizerRetain carton for complete product information
MANUFACTURED FOR:
Aramark
Lenexa, KS 66219
866-362-2691aramarkuniform.com
100 Tablet Box
250 Tablet Box
2-Tablet Packet
res
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INGREDIENTS AND APPEARANCE
ARAMARK MULTI-SYMPTOM COLD RELIEF
acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hbr tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81238-0107 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg Inactive Ingredients Ingredient Name Strength MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 12mm Flavor Imprint Code FR12 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81238-0107-1 50 in 1 BOX 05/14/2021 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:81238-0107-2 125 in 1 BOX 05/14/2021 2 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/14/2021 Labeler - Western First Aid Safety DBA Aramark (043861524) Registrant - Western First Aid Safety DBA Aramark (043861524) Establishment Name Address ID/FEI Business Operations ULTRA SEAL CORPORATION 085752004 pack(81238-0107) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 944090448 manufacture(81238-0107)