Label: XPECT COLD RELIEF- acetaminophen guaifenesein phenylephrine hcl tablet
- NDC Code(s): 42961-112-10, 42961-112-11, 42961-112-12
- Packager: Cintas Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 28, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purpose
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Uses
- temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: headache, nasal congestion, minor aches and pains, sinus congestion and pressure
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily reduces fever
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Warnings
Liver warning: This product contains acetaminophen. 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: blisters, rash, skin reddening. If a skin reaction occurs, stop use and seek medical help right away.
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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.
- if you have ever had an allergic reaction to this product or any of its ingredients
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product do not exceed recommended dosage.
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Stop use and ask a doctor if
- 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.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Questions?
- Principal Display Panel - Wrapper
-
Principal Display Panel - 80 count Box
COLD RELIEF
Active Ingredients:
Acetaminophen
Guaifenesin
Phenyleprine HCl
Pain Reliever/Fever Reducer
Expectorant
Nasal Decongestant
WORKPLACE READY®
- Single Dose
- Tamper Evident
Xpect® First aid
- Relieves Sinus Headache, Sinus Pressure, Nasal Congestion, Mucus, Chest Congestion
80 Caplets • 40 Packets per Box
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Principal Display Panel - 200 count box
COLD RELIEF
Active Ingredients:
Acetaminophen
Guaifenesin
Phenyleprine HCl
Pain Reliever/Fever Reducer
Expectorant
Nasal Decongestant
WORKPLACE READY®
- Single Dose
- Tamper Evident
Xpect® First aid
- Relieves Sinus Headache, Sinus Pressure, Nasal Congestion, Mucus, Chest Congestion
200 Caplets • 100 Packets per Box
-
INGREDIENTS AND APPEARANCE
XPECT COLD RELIEF
acetaminophen guaifenesein phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-112 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink Score no score Shape ROUND Size 12mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-112-11 80 in 1 BOX 03/29/2021 1 NDC:42961-112-10 2 in 1 PACKET; Type 1: Convenience Kit of Co-Package 2 NDC:42961-112-12 200 in 1 BOX 12/30/2022 2 NDC:42961-112-10 2 in 1 PACKET; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 03/29/2021 Labeler - Cintas Corporation (056481716) Establishment Name Address ID/FEI Business Operations L.N.K. International 832867837 manufacture(42961-112)